Home › China › BioRegen Biomedical (Changzhou) Co., Ltd.
Manufacturer of medical devices registered in the European database in Changzhou, Jiangsu, China.
| Registration number (SRN) | CN-MF-000007975 |
|---|---|
| Role | Manufacturer |
| Status | Active |
| Country | China |
| City | 213125 Changzhou, Jiangsu |
| Address | Building B, No. 117, Xueye Road, 213125 Changzhou, Jiangsu |
| Registered on | 2021-06-22 |
| FDA establishment register | Registered with the U.S. FDA |
|---|---|
| Matched entry | BIOREGEN BIOMEDICAL (CHANGZHOU) CO., LTD (CN) · FDA 3007327621 |
| Certificate | Status | Expiry | Type | Body |
|---|---|---|---|---|
G70 070340 0012 | valid | 2029-11-13 | Technical documentation | NB 0123 |
G12 070340 0015 | valid | 2029-12-02 | Quality management system | NB 0123 |
G10 070340 0011 | valid | 2029-12-02 | Quality management system | NB 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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