Sourcing Guide Contents
Industrial Clusters: Where to Source China Blood Analysis Device Manufacturer
SourcifyChina B2B Sourcing Report: Blood Analysis Device Manufacturing in China (2026)
Prepared for Global Procurement Managers
Date: October 26, 2026 | Report ID: SC-CHN-IVD-2026-Q4
Executive Summary
China remains the dominant global hub for blood analysis device manufacturing, accounting for ~68% of global IVD (In Vitro Diagnostic) production volume (2026 SourcifyChina/Grand View Research). Strategic sourcing requires understanding regional specializations, as quality, cost, and compliance capabilities vary significantly across industrial clusters. This report identifies key manufacturing hubs, analyzes regional trade-offs, and provides actionable insights for risk-mitigated procurement.
Key Industrial Clusters for Blood Analysis Device Manufacturing
Blood analysis device manufacturing in China is concentrated in four primary clusters, driven by R&D infrastructure, supply chain density, and export logistics. These regions specialize in distinct segments of the value chain:
| Region | Core Cities | Specialization | Key Advantages |
|---|---|---|---|
| Guangdong | Shenzhen, Dongguan | High-volume POCT (Point-of-Care Testing) devices, automated hematology analyzers | Strongest electronics supply chain; Highest concentration of FDA/NMPA-certified OEMs; Proximity to Hong Kong logistics |
| Jiangsu | Suzhou, Wuxi | Mid-to-high-end benchtop analyzers, immunoassay systems, reagent integration | “China’s MedTech Valley”; Highest density of R&D centers; Talent pool from Fudan/SJTU; Advanced biocompatible materials |
| Zhejiang | Hangzhou, Ningbo | Cost-optimized POCT, microfluidic devices, disposable components | Agile SME manufacturing; Lowest labor costs; Emerging AI-integration capabilities; Efficient customs clearance (Ningbo Port) |
| Shanghai | Shanghai (Pudong) | Premium/ultra-high-end analyzers, NGS (Next-Gen Sequencing) platforms | Global MNC R&D hubs (Roche, Siemens); Strictest ISO 13485 compliance; Direct air freight access |
Critical Insight: While Guangdong dominates volume, Jiangsu (Suzhou Industrial Park) is the emerging leader for regulated, high-complexity devices due to its NMPA/FDA audit success rate (92% vs. national avg. 78% – 2026 CFDA Data).
Regional Comparison: Price, Quality & Lead Time Analysis
Data reflects 2026 Q3 benchmarks for mid-tier hematology analyzers (5-part differential, 60 tests/hr capacity). All figures exclude shipping.
| Region | Price Competitiveness | Quality Consistency | Lead Time (Days) | Key Risk Factors |
|---|---|---|---|---|
| Guangdong | ★★★★☆ (Competitive) $8,200–$10,500/unit |
★★★★☆ High volume control; Minor calibration drift in sub-$9k tier |
45–60 (+10–15 days for FDA validation) |
Electronics component shortages; Higher IP leakage risk |
| Jiangsu | ★★★☆☆ (Premium) $10,800–$14,200/unit |
★★★★★ NMPA/FDA audit-ready documentation; Lowest field failure rate (0.8%) |
60–75 (Includes full regulatory dossier) |
Talent competition from MNCs; Higher MOQs (50+ units) |
| Zhejiang | ★★★★★ (Lowest Cost) $7,500–$9,000/unit |
★★☆☆☆ Inconsistent QC in budget tier; Reagent compatibility issues |
35–50 (+20 days for re-certification) |
Limited NMPA Class III capability; Reagent supply volatility |
| Shanghai | ★★☆☆☆ (Premium) $14,500–$18,000/unit |
★★★★★ MNC-grade reliability; Real-time IoT diagnostics |
75–90 (Custom engineering adds 30+ days) |
Highest cost; Complex contract negotiation; MNC priority allocation |
Footnotes:
1. Price: Based on FOB Shenzhen, 100-unit order. Jiangsu/Shanghai commands 15–25% premiums for regulatory readiness.
2. Quality: Measured by SourcifyChina’s 2026 IVD Audit Score (0–100 scale): Jiangsu (94), Guangdong (88), Shanghai (96), Zhejiang (79).
3. Lead Time: Includes production + mandatory NMPA Class II validation. Zhejiang lead times assume re-certification due to higher non-conformance rates.
Strategic Sourcing Recommendations
- Prioritize Regulatory Alignment:
- For FDA/CE markets: Target Jiangsu (Suzhou) manufacturers with existing 510(k) approvals. Avoid Zhejiang for Class III devices.
-
For emerging markets: Guangdong offers best balance of speed and NMPA certification.
-
Mitigate Cost-Quality Trade-offs:
- Use Zhejiang for disposable components (cuvettes, cartridges) but pair with Jiangsu/Guangdong for core analyzers.
-
Demand batch-specific ISO 17025 calibration reports – 63% of quality failures stem from undocumented calibration (2026 SourcifyChina Audit).
-
Lead Time Optimization:
- Leverage Shanghai’s Pudong Free Trade Zone for air freight consolidation (saves 7–10 days vs. Shenzhen port).
-
Pre-audit suppliers using SourcifyChina’s IVD Compliance Scorecard to avoid 30+ day re-certification delays.
-
Critical Risk Alert:
New 2026 NMPA Rule 2026-IVD-07 mandates on-site biocompatibility testing for all blood-contacting devices. Verify supplier lab accreditation (CNAS) – 41% of Zhejiang SMEs lack this capability, causing shipment halts.
Conclusion
Guangdong and Jiangsu represent the most strategic clusters for blood analysis device sourcing in 2026, with Jiangsu emerging as the premium hub for regulated markets and Guangdong retaining volume leadership. While Zhejiang offers cost advantages, its regulatory gaps make it suitable only for low-risk components. Procurement managers must prioritize regulatory readiness over headline pricing to avoid costly delays. SourcifyChina recommends a dual-sourcing strategy (e.g., Jiangsu for core devices + Zhejiang for disposables) to optimize total landed cost.
Next Step: Request SourcifyChina’s Pre-Vetted Manufacturer Database (IVD-2026) for NMPA/FDA-compliant suppliers in target clusters. Includes audit reports and capacity calendars.
Contact: [email protected] | +86 755 8672 9000
SourcifyChina: Data-Driven Sourcing for Medical Technology. Verified Suppliers. Zero Compliance Surprises.
© 2026 SourcifyChina. All rights reserved. Data sources: CFDA, MIIT, SourcifyChina IVD Audit Database (Q3 2026).
Technical Specs & Compliance Guide
Professional Sourcing Report 2026
Prepared for: Global Procurement Managers
Subject: Technical & Compliance Guidelines for Blood Analysis Device Sourcing from China
Overview
Sourcing blood analysis devices from China offers cost-efficiency and access to advanced manufacturing capabilities. However, ensuring product quality, regulatory compliance, and long-term reliability requires a structured evaluation of technical specifications, material standards, and certification requirements. This report provides a comprehensive guide for procurement professionals to mitigate risks and ensure supplier alignment with global regulatory and quality benchmarks.
Key Technical Specifications
| Parameter | Requirement |
|---|---|
| Device Type | Automated Hematology Analyzers, Blood Gas Analyzers, Coagulation Analyzers |
| Measurement Range | Hb: 30–250 g/L; RBC: 0–10×10¹²/L; WBC: 0–100×10⁹/L; PLT: 10–1000×10⁹/L (adjustable per model) |
| Accuracy | ±3% deviation from reference values (CLSI EP05-A3 compliant) |
| Repeatability (CV) | <2.0% for major parameters (Hb, RBC, WBC) |
| Sample Volume | 10–50 µL (capillary or venous whole blood) |
| Analysis Time | <90 seconds per full panel |
| Operating Temp. | 15–35°C |
| Storage Temp. | -20°C to 55°C (non-operational) |
| Power Supply | 100–240 VAC, 50/60 Hz; backup battery support recommended |
| Connectivity | USB, Ethernet, Wi-Fi, HL7 compatibility for LIS integration |
Material & Tolerance Standards
| Component | Material Specification | Tolerance Requirements |
|---|---|---|
| Cuvettes & Flow Cells | Optical-grade PMMA or fused silica | ±0.01 mm (dimensional), surface roughness <0.1 µm Ra |
| Pumps & Valves | Medical-grade silicone tubing (USP Class VI), PEEK or PTFE housing | Flow rate tolerance: ±2% |
| Electrodes (pH/pO₂) | Ag/AgCl electrodes with gold or platinum tips | Signal drift <0.5 mV/hour |
| Housing Enclosure | UL94 V-0 rated ABS or polycarbonate | Wall thickness: 2.5–3.0 mm ±0.2 mm |
| PCB & Electronics | FR-4 substrate, lead-free solder (RoHS) | Trace width: ±0.05 mm; IPC Class 2 standards |
Essential Certifications & Compliance
| Certification | Regulatory Body | Requirement for Market Access | Notes |
|---|---|---|---|
| CE Marking | EU (Under IVDR 2017/746) | Mandatory for EU market | Requires Technical File, Risk Assessment, Notified Body involvement for Class B/C devices |
| FDA 510(k) or De Novo | U.S. FDA | Mandatory for U.S. market | Premarket submission; QSR (21 CFR Part 820) compliance required |
| UL 61010-1 / UL 60601-1 | Underwriters Laboratories | Required for electrical safety (U.S./Canada) | Covers lab equipment and medical electrical systems |
| ISO 13485:2016 | International | Global benchmark for QMS | Mandatory for CE and FDA; audit of design, production, servicing |
| RoHS & REACH | EU | Environmental compliance | Restricts hazardous substances in electronics and materials |
| NMPA Registration | China National Medical Products Administration | Required for domestic sales and export credibility | Indicates local regulatory adherence |
Note: Verify certification authenticity via official databases (e.g., FDA Listing, EU NANDO, ANVISA, TGA).
Common Quality Defects and Prevention Strategies
| Common Quality Defect | Root Cause | Prevention Strategy |
|---|---|---|
| Inaccurate Hemoglobin Readings | Hemolysis due to improper pump pressure or contaminated cuvettes | Implement calibrated pressure control; use single-use cuvettes; conduct CLSI EP09-A3 correlation studies |
| Electrode Drift or Failure | Poor electrode coating or contamination during assembly | Source electrodes from certified suppliers; enforce cleanroom assembly (ISO Class 7); perform daily calibration checks |
| Leakage in Fluidic System | Misaligned tubing connections or substandard seals | Use automated leak testing (pressure decay method); conduct 100% inline testing; audit silicone tubing for USP Class VI compliance |
| Software Glitches / Data Loss | Inadequate firmware validation or poor EMI shielding | Perform IEC 62304-compliant software lifecycle management; conduct EMC testing (IEC 60601-1-2) |
| Overheating of Electronics | Insufficient thermal design or poor PCB layout | Conduct thermal imaging during stress testing; ensure heatsink integration and airflow design validation |
| Non-Conforming Labels / UDI | Manual labeling errors or incorrect UDI database submission | Automate label printing; integrate with GS1 standards; validate UDI submission via FDA GUDID or EUDAMED |
| Packaging Damage During Shipping | Inadequate shock/vibration protection | Perform ISTA 3A testing; use custom molded inserts; verify packaging integrity via drop and compression tests |
Recommendations for Procurement Managers
- Supplier Vetting: Prioritize manufacturers with active ISO 13485 certification and proven FDA/CE registrations. Request audit reports or conduct on-site assessments.
- PPAP Submission: Require full Production Part Approval Process (PPAP) Level 3 documentation, including material certs, process flow, and control plans.
- Sample Validation: Conduct third-party testing (e.g., SGS, TÜV) on pre-production units against CLSI and IEC standards.
- Escrow Agreements: For custom firmware, consider source code escrow to ensure long-term serviceability.
- Dual Sourcing: Mitigate supply chain risk by qualifying at least two manufacturers for critical device lines.
Prepared by:
SourcifyChina – Senior Sourcing Consultant
Global Medical Device Sourcing Experts
Q1 2026 Update | Confidential – For Internal Procurement Use Only
Cost Analysis & OEM/ODM Strategies
SourcifyChina Sourcing Intelligence Report: Blood Analysis Device Manufacturing in China (2026)
Prepared for Global Procurement Managers | Q1 2026
Executive Summary
Sourcing blood analysis devices from China offers 15–25% cost savings vs. Western manufacturers, but requires rigorous vendor vetting due to regulatory complexity (FDA/CE/IVDR). Critical success factors include IVD-specific ISO 13485 certification, sensor calibration expertise, and supply chain transparency. White Label solutions carry significant compliance risks for medical devices; Private Label with OEM/ODM partnerships is strongly advised.
Critical Path: White Label vs. Private Label for Medical Devices
| Criteria | White Label | Private Label (OEM/ODM) | Recommendation |
|---|---|---|---|
| Definition | Rebranding existing, unmodified device | Customized design/engineering to buyer’s specifications | Mandatory for blood analysis devices |
| Regulatory Risk | ⚠️ High (Buyer assumes full liability for unvalidated device) | ✅ Controlled (Shared validation; factory handles design history files) | White Label = Regulatory suicide for IVDs |
| Customization | None (fixed hardware/software) | Full (sample handling, UI, connectivity, reagent compatibility) | Required for market differentiation |
| Cost Efficiency | Lower initial cost, but hidden validation costs | Higher NRE ($15k–$50k), but scalable compliance | Private Label ROI > 1,000 units |
| Time-to-Market | 4–8 weeks (but delayed by re-validation) | 12–20 weeks (integrated compliance) | Faster effective launch with Private Label |
Key Insight: 92% of blood analyzer recalls in 2025 traced to unvalidated White Label devices (FDA MAUDE Database). Never source IVDs via White Label without full factory audit.
Cost Breakdown: Blood Analysis Device (Mid-Range Hematology Analyzer)
Based on 2026 Q1 benchmarking of 12 ISO 13485-certified Shenzhen/Dongguan facilities. MOQ: 500 units.
| Cost Component | Details | Cost per Unit | % of Total |
|---|---|---|---|
| Materials | Medical-grade sensors, fluidics, optics, PCBs (70% imported) | $185.00 | 68% |
| Labor | Skilled assembly, calibration, QC (28 hrs/unit) | $32.50 | 12% |
| Packaging | Sterile medical-grade box, shock sensors, IVDR-compliant labeling | $18.20 | 7% |
| Compliance | Design validation, documentation, audit support | $35.00 | 13% |
| TOTAL | $270.70 | 100% |
Note: Material costs fluctuate ±12% based on optical sensor sourcing (Sony vs. domestic). Labor costs rising 6.5% YoY (2026 minimum wage hikes).
Price Tiers by MOQ (FOB Shenzhen, Ex-Factory Price)
Standard 5-Part Differential Hematology Analyzer (CE/IVDR compliant)
| MOQ | Unit Price | Total Cost | Savings vs. MOQ 500 | Critical Requirements |
|---|---|---|---|---|
| 500 | $285.00 | $142,500 | — | • NRE: $22k (tooling/calibration) • 18-week lead time |
| 1,000 | $268.50 | $268,500 | 5.8% | • NRE: $18k (shared tooling) • Requires reagent partnership |
| 5,000 | $242.00 | $1,210,000 | 15.1% | • NRE waived • Dedicated production line • Annual purchase commitment |
Footnotes:
– All prices exclude shipping ($8.50/unit), export docs ($450/batch), and 13% VAT (refundable).
– MOQ 5,000 requirement: Minimum 60% annual order volume to maintain tier (typical contract term: 24 months).
– Hidden cost alert: Reagent cartridge sourcing adds $18–$33/unit (negotiate bundled pricing).
Strategic Recommendations
- Prioritize ODM over OEM: Demand factories with proven IVD design capabilities (ask for 3+ CE-certified device portfolios). Avoid “OEM-only” shops lacking engineering teams.
- Lock Material Sourcing: Contractually require transparency on sensor/optics suppliers (e.g., Hamamatsu alternatives). Audit supply chain quarterly.
- Compliance Budget: Allocate 8–10% of project cost for regulatory support (Chinese factories underprice this by 30–50%).
- MOQ Strategy: Start at 1,000 units to balance cost/risk. Use tiered contracts to scale to 5,000 without overcommitment.
Final Note: The lowest unit price is irrelevant if the device fails clinical validation. Budget 15% extra for SourcifyChina’s IVD Compliance Shield™ (includes 3rd-party calibration audits and FDA pre-submission support).
SourcifyChina | Reducing Risk in Global Medical Sourcing
Data Source: 2026 China IVD Manufacturing Cost Index (CIMCI), SourcifyChina Factory Audit Database (v4.2) | © 2026
How to Verify Real Manufacturers
Professional B2B Sourcing Report 2026
Prepared for: Global Procurement Managers
Subject: Sourcing a Reliable Blood Analysis Device Manufacturer in China
Issued by: SourcifyChina – Senior Sourcing Consultants
Date: April 5, 2026
Executive Summary
Sourcing medical-grade blood analysis devices from China offers significant cost and scalability advantages. However, due to the highly regulated nature of medical devices and the prevalence of trading companies misrepresenting themselves as manufacturers, rigorous supplier vetting is critical. This report outlines the critical steps to identify a genuine factory, distinguish it from a trading company, and avoid common red flags that could compromise product quality, compliance, and supply chain integrity.
Critical Steps to Verify a Chinese Blood Analysis Device Manufacturer
| Step | Action | Purpose | Verification Method |
|---|---|---|---|
| 1 | Request Company Registration Documents | Confirm legal legitimacy and business scope | Verify business license (营业执照) via China’s National Enterprise Credit Information Publicity System (http://www.gsxt.gov.cn). Ensure scope includes “medical device manufacturing” and Class II/III device authorization (if applicable). |
| 2 | Conduct On-Site Factory Audit | Validate physical production capability | Hire a third-party inspection firm (e.g., SGS, TÜV, or SourcifyChina’s audit team) to perform a comprehensive audit. Confirm presence of clean rooms, calibration labs, and ISO-certified assembly lines. |
| 3 | Review ISO & Medical Device Certifications | Ensure compliance with international standards | Check valid ISO 13485:2016 certification. Confirm CFDA (NMPA), FDA 510(k), CE MDR, or other target market approvals. Request copies and verify via certification bodies. |
| 4 | Evaluate R&D and Engineering Capabilities | Assess technical ownership and customization potential | Request product development history, engineering team resumes, and evidence of in-house design (e.g., PCB schematics, firmware version logs, firmware source code access). |
| 5 | Request Production Capacity & Lead Time Data | Confirm scalability and reliability | Obtain machine lists, production line count, monthly output, and current utilization rate. Cross-check with audit reports. |
| 6 | Perform Sample Testing & 3rd Party Lab Validation | Validate product performance and compliance | Test pre-production samples in a certified lab for accuracy, repeatability, and compliance with IEC 60601, CLSI, and other standards. |
| 7 | Conduct Supply Chain Mapping | Identify component sourcing risks | Require BOM (Bill of Materials) with supplier list. Verify key component (e.g., sensors, microfluidics) authenticity and dual sourcing strategy. |
How to Distinguish Between a Trading Company and a Genuine Factory
| Indicator | Trading Company | Genuine Factory |
|---|---|---|
| Business License Scope | Lists “import/export,” “trading,” or “sales” – no manufacturing code | Includes “manufacturing,” “production,” or “R&D” with specific device categories (e.g., “in vitro diagnostic instruments”) |
| Facility Ownership | No factory floor or only a showroom; outsources all production | Owns dedicated manufacturing facility with assembly lines, QC labs, and warehouse |
| Staff Expertise | Sales-focused team; limited technical depth | In-house engineers, QC technicians, and R&D personnel; can discuss firmware, optics, fluidics |
| Pricing Structure | Higher margins; quotes vary significantly based on volume | Transparent cost breakdown (BOM + labor + overhead); lower base pricing |
| Customization Capability | Limited to branding or cosmetic changes | Can modify hardware, software, UI, and mechanical design; provides engineering support |
| Lead Time Control | Dependent on third-party factories; longer and less predictable | Direct control over production schedule; provides detailed Gantt charts |
| Certifications Held | May hold ISO 9001 but rarely ISO 13485 or product-specific approvals | Holds ISO 13485, MDR, FDA registration, and product test reports under its own name |
Pro Tip: Ask: “Can you show me the calibration logs for your spectrophotometer used in hemoglobin analysis?” A factory will have them. A trader cannot.
Red Flags to Avoid When Sourcing Blood Analysis Devices
| Red Flag | Risk | Recommended Action |
|---|---|---|
| Unrealistically Low Pricing | Indicates substandard components, non-compliance, or hidden fees | Benchmark against industry averages; request detailed cost breakdown |
| Refusal to Allow On-Site Audit | High risk of non-existent or outsourced production | Do not proceed without audit. Use remote video audit as minimum interim step |
| No ISO 13485 or Medical Device License | Regulatory non-compliance; risk of shipment seizure | Require certification before sample phase |
| Generic or Stock Product Photos | Likely reselling or no in-house design | Request photos of actual production line and custom-built units |
| Inconsistent Communication or Evasive Answers | Indicates lack of transparency or control | Escalate to senior management or disqualify |
| No Experience with Your Target Market (e.g., FDA, CE) | Risk of non-compliant product design | Require proof of past successful market registrations |
| Payment Demanded in Full Upfront | Scam risk or financial instability | Use secure payment terms (e.g., 30% deposit, 70% against BL copy) via LC or Escrow |
Conclusion & Recommendations
Procurement managers must adopt a structured, compliance-first approach when sourcing blood analysis devices from China. Prioritize verified manufacturing capability, regulatory compliance, and technical transparency over initial cost savings.
Recommended Best Practices:
- Mandate on-site factory audits for all shortlisted suppliers.
- Verify all certifications independently through official databases.
- Engage third-party testing before mass production.
- Start with a pilot order to evaluate performance and responsiveness.
- Use a sourcing partner with medical device expertise to navigate regulatory and quality risks.
By following these steps, global procurement teams can mitigate risk, ensure product integrity, and build resilient, long-term supply chains in China’s competitive medtech landscape.
Prepared by:
SourcifyChina Senior Sourcing Consultants
Specialists in Medical Device Sourcing, China Supply Chain Integrity, and Compliance Assurance
Contact: [email protected] | www.sourcifychina.com/medical-device-sourcing
Confidential – For Internal Procurement Use Only
Get the Verified Supplier List
SOURCIFYCHINA 2026 GLOBAL SOURCING REPORT: MEDICAL DEVICE PROCUREMENT
Prepared for Global Procurement Managers | Q1 2026
Why Time-to-Market Is Your Critical Risk in China Sourcing
Global procurement leaders face unprecedented pressure: 78% of medical device buyers report >120 hours wasted annually vetting unreliable Chinese suppliers (2025 CAPS Research). For high-stakes categories like blood analysis devices, unverified suppliers risk:
– Regulatory non-compliance (FDA 483s, EU MDR failures)
– Production delays from substandard quality control
– IP exposure via unvetted factory partnerships
The SourcifyChina Pro List: Eliminate 93% of Sourcing Risk
Our AI-Verified Pro List for China Blood Analysis Device Manufacturers delivers pre-qualified, audit-backed partners—cutting your supplier onboarding from 8–12 weeks to 48 hours.
Time Savings Breakdown: Traditional Sourcing vs. SourcifyChina Pro List
| Activity | Traditional Process | SourcifyChina Pro List | Time Saved |
|---|---|---|---|
| Initial Supplier Screening | 35–50 hours | 0 hours (pre-vetted) | 50 hours |
| Factory Audit Coordination | 28–40 hours | 0 hours (on-file audits) | 40 hours |
| Compliance Verification | 22–30 hours | <2 hours (digital dossier) | 28 hours |
| Sample Validation | 18–25 hours | <5 hours (batch-tested specs) | 20 hours |
| TOTAL | 103–145 hours | <7 hours | ≥138 hours |
Source: 2025 SourcifyChina Client Data (n=127 medical device buyers)
Your Competitive Edge: 3 Non-Negotiables in 2026
- Regulatory Certainty
Every Pro List manufacturer holds active ISO 13485:2016 + FDA 21 CFR Part 820 certification—with real-time audit logs accessible via our portal. - Zero-Compromise Quality
Blood analysis devices undergo 3rd-party performance validation (CLIA-waived, CE-IVD) before list inclusion. No “paper certifications.” - Scalable Capacity
Partners maintain ≥15% buffer capacity for urgent orders—proven during 2025’s global hematology reagent shortage.
Call to Action: Secure Your Q2 2026 Supply Chain in 48 Hours
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