Selling a powered medical device across borders is a documentation problem as much as a product one. We hold the certificates and keep the technical files — and release them to verified buyers on enquiry.
Products carry the CE mark for placing on the European Economic Area market, declaring conformity with the applicable EU health and safety requirements.
Manufactured in line with the EU Medical Device Regulation, with technical documentation and an EU authorised representative for the market.
Production runs under a certified ISO 13485 medical-device quality management system — for design, manufacture and traceability.
Lithium batteries are tested to the UN38.3 standard for safe transport by air, sea and land.
The plant holds a Chinese medical-device manufacturing licence — a working, licensed production facility, not a trading desk.
Models are self-developed and patented, which supports exclusive and private-label programmes.
CE / MDR declarations of conformity, ISO certificates and test reports prepared for your market, released to verified buyers on enquiry.
We list only the certifications the factory holds. Ask us about market-specific registration and documentation support for your country.
CE / MDR declarations, ISO certificates, UN38.3 reports and product technical files are provided to distributors, importers and regulators under enquiry — with the documentation your customs and tenders ask for.
Tell us your market and we'll send the relevant certificates and reports.
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