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Hangzhou Alltest Biotech.Co.,Ltd.

Manufacturer of medical devices registered in the European database in Hangzhou, China.

Registration number (SRN)CN-MF-000010710
RoleManufacturer
StatusActive
CountryChina
City310018 Hangzhou
AddressYinhai Street, #550 310018 Hangzhou
Registered on2021-07-28

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entryHangzhou AllTest Biotech Co.,Ltd (CN) · FDA 3027519599

Notified body certificates

CertificateStatusExpiryTypeBody
V76 095123 0020supplemented2030-08-11Technical documentationNB 0123
V76 095123 0019supplemented2030-07-08Technical documentationNB 0123
EU-TDA-FI-51326-800081-2026valid2031-04-16Technical documentationNB 3018
EU-QMS-FI-08820-800081-2026valid2031-04-16Quality management systemNB 3018
EU-QMS-FI-08820-800081-2026valid2031-04-16Quality management systemNB 3018
CN26/00001622valid2031-03-10Quality management systemNB 1639

⚠️ State of the register on 2026-08-20. EUDAMED shows only the current version of a certificate — earlier versions are not published, by the Commission or by anyone. A certificate shown as valid here may have changed since. For a legally binding check, consult EUDAMED directly.

The SRN is the registration number assigned by the European Commission. It has been mandatory since 28 May 2026 for any operator placing a medical device on the Union market. Contact details are published in the official register; we do not reproduce them here.

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