Identity
- Trade Name
- ABENA Fixation Dressing EUDAMED
- Device Name
- Non-woven wound dressing for fixation EUDAMED
- Model / Reference
- 603-015501 EUDAMED603-015502 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941094089004 EUDAMED06941094089257 EUDAMED
- Basic UDI-DI
- 694109405489FS EUDAMED
- EMDN Code
- M04010201 NON-WOVEN FIXING DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
ABENA Fixation Dressing by Winner Medical 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 | 694109405489FS | Class I | 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 05f16f8d-cf66-40da-ad98-d0a8ac945604 61 fields · synced Jul 25, 2026
- EUDAMED 2063c13a-c89e-4503-acef-3baf13fbce53 61 fields · synced May 19, 2026