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Fixative Bandage 400x6 cm +1 more model
EUDAMEDClass I (EU MDR)
Ref 42295Model FB6, FB8
Identity
- Trade Name
- Fixative Bandage 400x6 cm; 5 Units each 2 pcs EUDAMED
- Device Name
- First Aid Dressing Bandage EUDAMED
- Model / Reference
- FB6, FB8 EUDAMED42295 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454716624 EUDAMED
- Basic UDI-DI
- 69514547300UW EUDAMED
- EMDN Code
- M0303010103 ELASTIC FIXING BANDAGES, NON-ADHESIVE, EXTENSIBLE IN TWO DIRECTIONS EUDAMED
- Models / Variants
- Fixative Bandage 400x6 cm EUDAMED5 Units each 2 pcs EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Fixative Bandage 400x6 cm +1 more model by Gauke Healthcare Co., Ltd — Class I — MDR — listed in EUDAMED — 2 models — 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 | 69514547300UW | Class I | Active |
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Manufacturer
- Manufacturer
- GAUKE Healthcare Co., Ltd
- EUDAMED SRN
- CN-MF-000013784
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 0d0a576d-2fc6-499c-ad14-79a7a501874f 61 fields · synced Oct 7, 2026