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Duramax N
EUDAMEDClass IIb (EU MDR)
Ref 66807734Model Super Absorbent Dressing (TYPE VI)Ref 66807731Ref 66807732Ref 66807730Ref 66807733
Identity
- Trade Name
- DURAMAX N EUDAMED
- Device Name
- Super Absorbent Dressing EUDAMED
- Model / Reference
- Super Absorbent Dressing (TYPE VI) EUDAMED66807734 EUDAMED66807731 EUDAMED66807732 EUDAMED66807730 EUDAMED66807733 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942327048225 EUDAMED06942327041912 EUDAMED06942327062016 EUDAMED06942327078109 EUDAMED06942327062306 EUDAMED
- Basic UDI-DI
- 694232708229FK EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER 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
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Duramax N by Winner Medical Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
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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 | 694232708229FK | 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 (5)
- EUDAMED b7d5dc6c-3553-4177-a972-4c42c27ca8c2 61 fields · synced Sep 17, 2026
- EUDAMED a1787f39-87f9-46e1-b403-a7de2ab7a6dc 61 fields · synced May 17, 2026
- EUDAMED 851fd007-1be5-48a2-a611-c641d076f2e8 61 fields · synced May 18, 2026
- EUDAMED b3e35481-5534-4073-a115-53740fd2698c 61 fields · synced May 18, 2026
- EUDAMED b03448c3-c893-405d-b7a7-686078349881 61 fields · synced May 19, 2026