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Acon Biotech (Hangzhou) Co., Ltd.

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

Registration number (SRN)CN-MF-000006977
RoleManufacturer
StatusActive
CountryChina
City310030 Hangzhou
AddressZhenzhong Road, No.210 310030 Hangzhou
Registered on2021-06-08

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entryACON BIOTECH (HANGZHOU) CO., LTD. (CN) · FDA 9615507

Notified body certificates

CertificateStatusExpiryTypeBody
V76 042074 0046valid2031-07-20Technical documentationNB 0123
V76 042074 0045valid2031-07-12Technical documentationNB 0123
V76 042074 0044valid2031-07-13Technical documentationNB 0123
V76 042074 0043valid2031-07-12Technical documentationNB 0123
V13 042074 0039supplemented2030-04-09Quality management systemNB 0123

⚠️ 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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