Identity
- Trade Name
- Gauze Bandage EUDAMED
- Device Name
- Gauze Bandage EUDAMED
- Model / Reference
- ENGBX3AA001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974686056863 EUDAMED
- Basic UDI-DI
- 697468605GBX3AA020JT EUDAMED
- EMDN Code
- M020107 COTTON GAUZES IN ROLLS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Gauze Bandage by Yiwu Ori-Power Medtech 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 | 697468605GBX3AA020JT | Class I | Active |
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Manufacturer
- Manufacturer
- Yiwu Ori-Power Medtech Co., Ltd.
- EUDAMED SRN
- CN-MF-000021146
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 2b202b8c-2c35-41d4-a1ac-dd6e73d85272 61 fields · synced Jun 18, 2026