Identity
- Trade Name
- Non woven STERILE gauzes EUDAMED
- Device Name
- Sterile Non-woven Swab without X-Ray EUDAMED
- Model / Reference
- 05383-u EUDAMED05384-u EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948788166492 EUDAMED06948788166454 EUDAMED
- Basic UDI-DI
- 694878811*004E2 EUDAMED
- EMDN Code
- M0202010101 NON-WOVEN FOLDED GAUZES, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
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
Non woven STERILE gauzes 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*004E2 | 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 (2)
- EUDAMED a41273d7-be54-46ba-aa43-74410e2d17d8 61 fields · synced Oct 6, 2026
- EUDAMED 80506693-2350-4aef-ae79-52c9cbd9c144 61 fields · synced May 18, 2026