Identity
- Trade Name
- sterile absorbent gauze dressing EUDAMED
- Device Name
- Sterile Absorbent Gauze Dressing EUDAMED
- Model / Reference
- 102-202508 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454734031 EUDAMED
- Basic UDI-DI
- 69514547313V7 EUDAMED
- EMDN Code
- M020106 COTTON GAUZES IN PIECES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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 | 69514547313V7 | 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 821159ca-96ef-447b-868f-b4c4c21fd756 61 fields · synced Oct 7, 2026