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Synthetic non-woven products with X-ray detectable element
EUDAMEDClass IIa (EU MDR)
Ref 187812
Identity
- Device Name
- Synthetic non-woven products with X-ray detectable element EUDAMED
- Model / Reference
- 187812 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16941094044857 EUDAMED
- Basic UDI-DI
- 694109405474FD EUDAMED
- EMDN Code
- M0202010201 NON-WOVEN FOLDED GAUZES, WITH X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
Synthetic non-woven products with X-ray detectable element by Winner Medical Co., Ltd. — Class IIa — 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 | 694109405474FD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Winner Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000005692
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 2ea0914f-9992-4b7e-92c1-d2b12e6a04f0 61 fields · synced Jul 25, 2026