Identity
- Trade Name
- FIX FIRST EUDAMED
- Device Name
- Sterile Gauze Swab without X-Ray EUDAMED
- Model / Reference
- 205100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08719324121538 EUDAMED
- Basic UDI-DI
- 694878811*005E4 EUDAMED
- EMDN Code
- M0201010101 COTTON GAUZE, CUT, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Fix First by Hubei Qianjiang Kingphar Medical Material Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 694878811*005E4 | Class I | Active |
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Manufacturer
- Manufacturer
- Hubei Qianjiang Kingphar Medical Material Co., Ltd
- EUDAMED SRN
- CN-MF-000009051
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED abfb179f-e185-4b5b-b94a-5d1b588267ae 61 fields · synced Jun 19, 2026