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CMC Gelling Fiber Dressing Standard (Type II)
EUDAMEDClass IIb (EU MDR)
Ref 4051 1808Ref 4051 1806Ref 4051 1807
Identity
- Trade Name
- CMC Gelling Fiber Dressing Standard (Type II) EUDAMED
- Device Name
- CMC Gelling Fiber Dressing Standard (Type II) EUDAMED
- Model / Reference
- 4051 1808 EUDAMED4051 1806 EUDAMED4051 1807 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942327041520 EUDAMED16942327009735 EUDAMED16942327041513 EUDAMED
- Basic UDI-DI
- 694232707878GP 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
- 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
CMC Gelling Fiber Dressing Standard (Type II) 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 | 694232707878GP | 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 (3)
- EUDAMED 6c598589-fab5-42fe-bc6e-b950d07f0bcb 61 fields · synced Aug 1, 2026
- EUDAMED 6f925b3e-61cc-47e7-97fb-ac8dbf536677 61 fields · synced May 17, 2026
- EUDAMED ab45ea08-9f9e-4981-ab62-0493471a4329 61 fields · synced May 19, 2026