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First Aid Dressings Bandages
EUDAMEDClass I (EU MDR)
Ref F003Model FB6, FB8Ref F004Ref F031
Identity
- Trade Name
- First Aid Dressings Bandages EUDAMED
- Device Name
- First Aid Dressing Bandage EUDAMED
- Model / Reference
- FB6, FB8 EUDAMEDF003 EUDAMEDF004 EUDAMEDF031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454700036 EUDAMED06951454700043 EUDAMED06951454702306 EUDAMED
- Basic UDI-DI
- 69514547300UW EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMEDEUDAMED
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
First Aid Dressings Bandages by Gauke Healthcare 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 | 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 (3)
- EUDAMED 2bdfca23-ea29-4935-a4fa-3772fbb3601e 61 fields · synced Oct 6, 2026
- EUDAMED 734ddb2a-b9ef-465d-a7f6-4333f88cda29 61 fields · synced May 17, 2026
- EUDAMED aa1ae4a7-4b52-43db-ba51-fdc5b5de7dda 61 fields · synced May 18, 2026