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CMC Gelling Fiber Dressing Standard (Type I)
EUDAMEDClass IIb (EU MDR)
Ref ahc-HF101010Ref ahc-HF452005
Identity
- Trade Name
- CMC Gelling Fiber Dressing Standard (Type I) EUDAMED
- Device Name
- CMC Gelling Fiber Dressing EUDAMED
- Model / Reference
- ahc-HF101010 EUDAMEDahc-HF452005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942327002088 EUDAMED16942327045979 EUDAMED
- Basic UDI-DI
- 694109403524EM EUDAMED
- EMDN Code
- M040404 CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
CMC Gelling Fiber Dressing Standard (Type I) by Winner Medical Co., Ltd. — Class IIb — 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 | 694109403524EM | Class IIb | 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 (2)
- EUDAMED 8353ffc1-615d-48ba-9fb8-ac373949cd3d 61 fields · synced Jul 20, 2026
- EUDAMED 9a84d4dc-da76-43a4-b803-4eaa2ecdfccd 61 fields · synced May 18, 2026