Identity
- Trade Name
- Sterile absorbent gauze dressing EUDAMED
- Device Name
- Absorbent cotton dressing EUDAMED
- Model / Reference
- gauke-10x10-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454797449 EUDAMED
- Basic UDI-DI
- 69514547310UZ EUDAMED
- EMDN Code
- M020106 COTTON GAUZES IN PIECES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Slovenia 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
Sterile absorbent gauze dressing 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 | 69514547310UZ | 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 b13df002-1773-41fe-9191-01eb2950ea77 61 fields · synced Jun 19, 2026