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Adhesive bandages
EUDAMEDClass I (EU MDR)
Ref F002-2Model Non-woven、PE、Elastic fabric、Elastic fabric
Identity
- Trade Name
- Adhesive bandages EUDAMED
- Device Name
- Adhesive bandage EUDAMED
- Model / Reference
- Non-woven、PE、Elastic fabric、Elastic fabric EUDAMEDF002-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454776703 EUDAMED06951454702290 EUDAMED
- Basic UDI-DI
- 69514547302V2 EUDAMED
- EMDN Code
- M03030202 SKIN PROTECTIVE BANDAGES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMEDPoland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDEUDAMED
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
Adhesive bandages by Gauke Healthcare Co., Ltd — Class I — CE/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 | 69514547302V2 | 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 (2)
- EUDAMED 31241f62-361d-44e7-a7fa-0a9845c9edec 61 fields · synced Oct 7, 2026
- EUDAMED 1dec7be6-cc5e-407e-a9f7-71a92877806b 61 fields · synced May 19, 2026