Home › China › GenSure Biotech Inc.
Manufacturer of medical devices registered in the European database in Shanghai, China.
| Registration number (SRN) | CN-MF-000028354 |
|---|---|
| Short name | GenSure |
| Role | Manufacturer |
| Status | Active |
| Country | China |
| City | 201114 Shanghai |
| Address | 5F, No. 5, Lane 396, Luzhouhuan Rd., Minhang District, 201114 Shanghai, China., 201114 Shanghai |
| Registered on | 2022-09-12 |
| FDA establishment register | Not found in the U.S. FDA register |
|---|
⚠️ Not found is not the same as not registered. The two registers share no common identifier; the comparison is made on company names. This manufacturer may reach the United States through a distributor, or be registered under a name we could not match. State of the FDA register on 2026-08-20.
| Certificate | Status | Expiry | Type | Body |
|---|---|---|---|---|
V76 126886 0006 | valid | 2030-07-13 | Technical documentation | NB 0123 |
V76 126886 0005 | valid | 2030-07-10 | Technical documentation | NB 0123 |
V76 126886 0004 | valid | 2030-07-15 | Technical documentation | NB 0123 |
V76 126886 0003 | valid | 2030-07-15 | Technical documentation | NB 0123 |
V13 126886 0002 | valid | 2030-07-15 | Quality management system | NB 0123 |
6211186TD01 | valid | 2031-01-01 | Technical documentation | NB 0344 |
6211186CE01 | valid | 2031-01-01 | Quality management system | NB 0344 |
⚠️ 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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