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Manufacturer of medical devices registered in the European database in Taichung City, Taiwan.
| Registration number (SRN) | TW-MF-000008450 |
|---|---|
| Role | Manufacturer |
| Status | Active |
| Country | Taiwan |
| City | 40242 Taichung City |
| Address | Sec.2, Daqing St., South Dist., No. 100 40242 Taichung City |
| Registered on | 2021-06-28 |
| FDA establishment register | Registered with the U.S. FDA |
|---|---|
| Matched entry | BIONIME CORPORATION (TW) · FDA 3004183148 |
| Certificate | Status | Expiry | Type | Body |
|---|---|---|---|---|
MDR 832658 | valid | 2031-07-09 | Quality management system | NB 2797 |
IX 2110160-1 | valid | 2031-07-22 | Technical documentation | NB 0197 |
HX 2110160-1 | valid | 2031-07-22 | Quality management system | NB 0197 |
⚠️ 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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