Identity
- Trade Name
- GBUK Foam EUDAMED
- Device Name
- foam dressings EUDAMED
- Model / Reference
- F0505 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938056216165 EUDAMED
- Basic UDI-DI
- B-06938056216165 EUDAMED
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
GBUK Foam by Zhejiang Hongyu Medical Commodity Co., Ltd — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06938056216165 | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Hongyu Medical Commodity Co., Ltd
- EUDAMED SRN
- CN-MF-000008204
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED bdfb43b5-c04e-4b97-921b-8bbd94dcac29 61 fields · synced Oct 7, 2026