Identity
- Trade Name
- Sterile gauze pads EUDAMED
- Device Name
- Absorbent non woven Compress EUDAMEDSterile Absorbent Gauze Dressing EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454784593 EUDAMED06951454708445 EUDAMED06951454772231 EUDAMED06951454762980 EUDAMED
- Basic UDI-DI
- 69514547317VF EUDAMED69514547313V7 EUDAMED
- EMDN Code
- M040204 NON-ADHERENT ABSORBENT DRESSINGS EUDAMEDM020106 COTTON GAUZES IN PIECES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 gauze pads 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 | 69514547317VF | 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 (4)
- EUDAMED 4eaa89df-c580-4938-9c67-84bc544ac3cc 61 fields · synced Oct 6, 2026
- EUDAMED ca56a993-c0fb-40f5-8058-9aabc5227f15 61 fields · synced May 18, 2026
- EUDAMED fd341794-9cea-436b-be7f-d45daf33e5c8 61 fields · synced Jul 8, 2026
- EUDAMED 2905d1f6-8d0a-4061-8925-e8b9d2b9f7bc 61 fields · synced Aug 1, 2026