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GBUK Silicone wound contact layer
EUDAMEDClass IIb (EU MDR)
Ref SWCD1215Model silcone
Identity
- Trade Name
- GBUK Silicone wound contact layer EUDAMED
- Device Name
- silicone dressings EUDAMED
- Model / Reference
- silcone EUDAMEDSWCD1215 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938056216271 EUDAMED
- Basic UDI-DI
- 69380562SD004NE EUDAMED
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED 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
GBUK Silicone wound contact layer by Zhejiang Hongyu Medical Commodity 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 | 69380562SD004NE | Class IIb | Active |
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Manufacturer
- Manufacturer
- Zhejiang Hongyu Medical Commodity Co., Ltd
- EUDAMED SRN
- CN-MF-000008204
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED a2f5d291-8bf3-4aa4-8675-512ca546b08c 61 fields · synced Jun 20, 2026