Home / Quality & certifications — the verified list
Quality & certifications — the verified list
FDA establishment reg.3006636961
510(k) clearances verified5 model families
Quality systemISO 13485:2016
EU complianceCE under MDR 2017/745
This page lists only what has been verified against primary sources. Where a claim could not be tied to a document — a clearance number, a registration, a certificate scope — it is not published. Certificates for the models they cover are available upon request during quotation.
Medlinket's US FDA establishment registration number is 3006636961. Five 510(k) clearances have been verified by number, applicant name and product scope; they cover the core of the catalogue sold into the US market.
FDA 510(k) clearances — verified by number
K083010 — adult SpO2 sensors (finger-clip and silicone soft-tip). K182667 — temperature probes. K202743 — the Med-Link pulse oximeter device. K210441 — incontinence probe (a cleared Med-Link product outside this site's monitoring-accessory catalogue). K193338 — reusable and disposable temperature probes. Clearance applies to the listed model families; when you request a quotation for the US market, ask for the clearance reference that covers your exact model and we will confirm it in writing.
CE marking and quality system
Products for the European market are CE marked under the EU Medical Device Regulation 2017/745 (MDR). The quality management system is certified to ISO 13485:2016. For the Chinese domestic market, products hold NMPA registrations as applicable. We deliberately publish standard names and verified clearance numbers only — no certificate numbers beyond these, and no certificate images — because document-level verification belongs in the supply agreement, not in marketing copy; full documents are shared during supplier qualification.
Production quality controls
Sensor assembly takes place in a class-100,000 cleanroom. Cable production, mould processing and final testing are in-house, which keeps the three most common accessory failure points — connector solder joints, cable conductor fatigue and sensor optical alignment — under one quality system. Every production lot is traceable to its model, and the standard warranty across most of the catalogue is twelve months (confirm the term for your model in the quotation).
Questions & answers
Can I get copies of certificates?
Yes — certificates and 510(k) documentation for the models they cover are available upon request as part of supplier qualification.
Does the FDA clearance cover every product on this site?
No. Clearances cover specific model families (see the five verified numbers above). Compatibility accessories for other markets are supplied under the regulatory route that applies there; ask us to confirm the status of your exact model.
What warranty do products carry?
Twelve months is the standard term across most of the catalogue, stated per product. The exact term for your model is confirmed in the quotation.