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Silicone Super Absorbent Dressing
EUDAMEDClass IIb (EU MDR)
Ref 18794578Model Silicone Super Absorbent Dressing without border (Type I)
Identity
- Device Name
- Silicone Super Absorbent Dressing EUDAMED
- Model / Reference
- Silicone Super Absorbent Dressing without border (Type I) EUDAMED18794578 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942327081991 EUDAMED
- Basic UDI-DI
- 694109403530EG EUDAMED
- EMDN Code
- M04040702 SILICONE DRESSINGS, 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
Silicone Super Absorbent Dressing 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 | 694109403530EG | 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 (1)
- EUDAMED 4938bd6e-b94b-4a4c-927d-7fff20a280ae 61 fields · synced Jun 18, 2026