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Easy access bandages
EUDAMEDClass I (EU MDR)
Ref FRC-EAB6+FRC-EAB4Model Non-woven、PE、Elastic fabric、Elastic fabricRef FRC-EAB24+FRC-EAB16
Identity
- Trade Name
- Easy access bandages EUDAMED
- Device Name
- Adhesive bandage EUDAMED
- Model / Reference
- Non-woven、PE、Elastic fabric、Elastic fabric EUDAMEDFRC-EAB6+FRC-EAB4 EUDAMEDFRC-EAB24+FRC-EAB16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454776956 EUDAMED06951454709961 EUDAMED
- Basic UDI-DI
- 69514547302V2 EUDAMED
- EMDN Code
- M03030202 SKIN PROTECTIVE BANDAGES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Easy access 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 | 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 5e453372-05de-449f-87a8-2f233fd09483 61 fields · synced Oct 6, 2026
- EUDAMED 456640a8-6828-4ee9-a1bb-3ec998bdb1a6 61 fields · synced May 18, 2026