What this page does. If you are a hospital BMET, procurement officer or distribution partner evaluating MedLinket, you eventually want to know: where are these accessories actually made, and how? This page is the operational disclosure — two self-owned factories, complete in-house manufacturing chain, QC checkpoints, bend-test data, material specifications and production lead times. This is not a marketing brochure.
The two factories
Shenzhen factory — HQ manufacturing base
Location: Hualian Industrial Zone, Xinshi Community, Dalang Street, Longhua District, Shenzhen. Function: headquarters production, R&D-integrated manufacturing, SpO2 sensor final assembly, advanced product variants. Established: 2004. Workshops: R&D centre, mold workshop, medical cable extrusion workshop, connector production workshop, Class 100,000 cleanroom, finished-goods warehouse.
Shaoguan factory — production expansion base
Location: Shaoguan, Guangdong Province. Function: production expansion, high-volume cable and reusable sensor manufacturing, redundant capacity for supply continuity. Workshops: aligned with Shenzhen capabilities, focused on high-volume reusable product lines.
Why two factories. Hospitals and distributors increasingly evaluate supplier resilience. Two factories in different cities provide geographic risk diversification, production capacity that can flex to peak demand, independent QC environments, and continued production during planned maintenance shutdowns. A single-factory supplier is one event away from supply interruption.
The in-house manufacturing chain
R&D centre (co-located with Shenzhen production)
Co-location closes the design-to-production loop: a design engineer can walk to the production line, observe an assembly step and revise the design within hours. The R&D centre is responsible for new sensor and cable design, OEM cross-reference research, design validation (with the Adapter Lab and Sun Yat-sen Memorial Hospital for clinical validation), and customer-specific OEM/ODM projects.
Mold workshop
The mold workshop produces tooling for connector housings, sensor bodies (silicone over-moulding), cable strain reliefs and disposable component cavities. In-house mold production reduces lead time from "design specification" to "first production unit" from 8–12 weeks (external mold supplier) to 4–6 weeks. MedLinket's current mold inventory of 2,822 pieces represents accumulated tooling across over 20 years of product development.
Medical cable extrusion workshop
Medical cables require biocompatible jacket materials (PVC, TPE or silicone), specific shielding for IEC 60601-1-2 EMC compliance, stranded conductor geometry that survives 20,000+ flex cycles, and dimensional consistency for tight-fit boots and connector strain reliefs. In-house extrusion gives direct control over conductor specification, jacket material and shield design.
Connector production workshop
Covers connector housing moulding, pin insertion and crimping, cable-to-connector strain-relief over-moulding, and per-unit electrical continuity test. A single SpO2 sensor cable involves 7–14 pins, each needing accurate crimp force, retention and electrical continuity.
Class 100,000 cleanroom
Sensor final assembly — optical assembly (LED and photodiode placement) and silicone over-moulding — happens in a Class 100,000 cleanroom per ISO 14644-1. Controls include HEPA-filtered air handling with regular particle-count monitoring, garment protocol, operator training per ISO 13485 work instructions, and material-flow controls to prevent cross-contamination between product lines.
QC checkpoints
| Checkpoint | What is verified | Sample rate | Failure handling |
|---|---|---|---|
| Incoming material inspection | Component conformance: LED wavelength, photodiode response, cable conductor resistance, silicone material lot, connector pin retention | 100% lot identity; sampled material property test | Reject lot on failure; supplier corrective action |
| In-process — connector | Pin insertion accuracy, crimp force within spec, strain-relief over-moulding integrity | Every unit visually; sampled mechanical test | Rework; root cause if multiple defects per operator |
| In-process — sensor body | Optical assembly placement, silicone over-moulding cure quality | Every unit visually; sampled optical test | Reject defective unit |
| Per-unit electrical continuity | Pin continuity, cross-pin isolation, LED activation, photodiode response, cable shield integrity | 100% of units | Reject; rework if recoverable |
| Per-unit functional test | Correct SpO2 reading on reference simulator at SaO2 75%, 85%, 95%, 100% and PI = 1.0 | 100% of units | Reject defective unit |
| Pre-pack visual inspection | Cable boot bond integrity, label legibility, package seal | Every unit | Rework if cosmetic; reject if structural |
| Pre-shipment audit | Sampled re-test of finished units against the full test sequence | Sampled (typically 5 units per lot) | Hold lot pending re-test if any audit unit fails |
The two 100%-of-units checkpoints — electrical continuity and functional test — are the core of shipment QC. They take additional production time but catch unit-level manufacturing defects that sampled QC would miss.
Cable bend and cycle test data
The most common cable-failure mode in clinical use is bend fatigue at the strain relief. MedLinket cables are tested per IEC 60601-2-49: cable specimen mounted with the strain-relief end clamped; free end cycled ±90° from neutral at 60 cycles per minute; cycle count to failure (electrical discontinuity, jacket crack, or shield integrity loss).
| Test | IEC 60601-2-49 pass criterion | Standard cable | Reinforced strain relief |
|---|---|---|---|
| Strain-relief bend cycles to failure | 5,000+ cycles | 8,000–12,000 cycles | 20,000+ cycles |
| Connector mating cycles | 1,000+ cycles | 1,500–2,500 cycles | 2,500–5,000 cycles |
| Cable jacket cleaning resistance (200 cycles, isopropyl 70%) | No cracking, peeling or colour change | Pass | Pass |
| Tensile strength at connector boot | 50 N minimum pull | 80–120 N | 100–150 N |
The reinforced strain-relief variant uses MedLinket's wide-grid dust-resistant strain-relief patent (filed 2018), which provides a graduated stiffness transition at the cable exit, reducing the lever arm when users disconnect by pulling on the cable rather than gripping the connector body. This directly addresses the 51% cable-damage failure mode identified in field return analysis.
Material specifications
- Patient-contact silicone: USP Class VI medical-grade, tested per ISO 10993-5 and ISO 10993-10; latex-free; validated against common hospital disinfectants for 200 cleaning cycles; 5-year shelf life when stored per spec.
- Cable jacket: TPE or medical-grade PVC (reusables); PVC single-patient-use validated (disposables); stranded copper conductor typically 26 AWG or finer for SpO2.
- Connector pins: gold-plated brass or beryllium copper; pin retention force typically 1.5–3.0 N initial, retained through 1,500+ mating cycles.
- Cable shielding: braided or spiral-wrapped tinned copper, ≥85% coverage per IEC 60601-1-2, low-resistance solder bond at shield termination.
Production lot sizing and lead times
| Product category | Typical lot size | Production lead time | Lot validation time | Total lead time |
|---|---|---|---|---|
| Standard reusable SpO2 (high-volume SKU) | 5,000 units | 2–3 weeks | 6 weeks | 8–9 weeks |
| Standard reusable SpO2 (medium-volume SKU) | 1,000–2,000 units | 1–2 weeks | 6 weeks | 7–8 weeks |
| Disposable SpO2 sensor | 5,000–20,000 units | 2–3 weeks | 3–4 weeks | 5–7 weeks |
| ECG trunk cable (standard) | 2,000–5,000 units | 2 weeks | 4 weeks | 6 weeks |
| NIBP reusable cuff | 5,000+ units | 3 weeks | 3 weeks | 6 weeks |
| Custom OEM/ODM (first run) | 500–2,000 units | 6–8 weeks (incl. tooling if new) | 8 weeks (incl. design validation) | 14–16 weeks |
What is outsourced — honest disclosure
- Raw material production: we do not smelt copper, polymerise silicone or grow gold. Raw materials come from qualified suppliers under incoming inspection protocol.
- Calibration of test equipment: reference instruments go to NIST-traceable calibration labs at scheduled intervals (typically 12 months).
- Sterilisation of disposable products: where required, sterilisation (typically gamma irradiation) is done by qualified external sterilisation service providers; sterilisation validation and dose mapping are part of our QMS.
- Clinical validation hosting: the Sun Yat-sen Memorial Hospital hypoxia chamber is a hospital facility, not a MedLinket facility. We arrange validation testing there per ISO 80601-2-61 protocol, but the facility and clinical staff are independent.
Frequently asked questions
Are MedLinket products manufactured in China?
Yes — both factories are in Guangdong Province, China. We are a Chinese-founded, Chinese-manufactured medical accessory company that exports to 117 countries and regions.
What is the minimum order quantity?
For standard catalogue products, typical MOQ is 100–500 units. For custom OEM/ODM designs, the first-production-run MOQ is typically 500–1,000 units to amortise tooling and validation costs.
How do I verify the factory is real?
Several ways: request a video walkthrough; request a factory audit (we have been audited by China's NMPA, the U.S. FDA and Brazil's ANVISA and host customer-driven audits on a scheduled basis); or search our NEEQ public listing (stock code 833505) for company registration records. A step-by-step method is in How to verify a medical accessory supplier on the FDA database.
What is your defect rate?
Per-unit electrical QC catches and rejects 0.4–1.2% of units before shipment, depending on product line. Field return rate for verified product defects (excluding mishandling) runs at approximately 0.3–0.6% across the active catalogue. Both figures are tracked in the QMS and audited annually.
About MedLinket. Founded 2004 in Shenzhen Longhua District by Mr. Ye Maolin. NEEQ-listed (stock code 833505) — the first listed company of patient-monitor accessories in China. Over 20 years specialising in patient-monitoring accessories. Two self-owned factories (Shenzhen and Shaoguan). FDA 510(k), CE, MHRA, MDSAP, ISO 13485:2016 (TÜV), ISO 9001 certified. On-site audits passed by China NMPA, U.S. FDA and Brazil ANVISA. Product liability insurance with cover up to USD 5 million; Additional Insured endorsement available to hospital customers on request.
