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GBUK Film Dressing
EUDAMEDClass I (EU MDR)
Ref TF2030Model PURef TF1020Ref TF0607Ref TF044044
Identity
- Trade Name
- GBUK Film Dressing EUDAMED
- Device Name
- I.V.dressings EUDAMED
- Model / Reference
- PU EUDAMEDTF2030 EUDAMEDTF1020 EUDAMEDTF0607 EUDAMEDTF044044 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938056216431 EUDAMED06938056216448 EUDAMED06938056216349 EUDAMED06938056216332 EUDAMED
- Basic UDI-DI
- 69380562IV001NQ EUDAMED
- EMDN Code
- M04010202 POLYURETHANE FIXING DRESSINGS EUDAMED
Classification
- Device Class
- Class I 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 Film Dressing by Zhejiang Hongyu Medical Commodity 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 | 69380562IV001NQ | Class I | 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 (4)
- EUDAMED 7ab6f8f8-3939-45b7-8406-d66e6f5cc9a4 61 fields · synced Oct 6, 2026
- EUDAMED 115f3f91-d749-4b5a-aa2a-f63fb7cbccf9 61 fields · synced May 17, 2026
- EUDAMED 306c086b-88a5-40e6-98bd-8e0b08fd8747 61 fields · synced May 17, 2026
- EUDAMED 5da35c0e-10f5-4b6b-906d-32d17a5df054 61 fields · synced May 18, 2026