Identity
- Trade Name
- Gauze balls EUDAMED
- Device Name
- Gauze swabs/balls/rolls EUDAMED
- Model / Reference
- I EUDAMED800-070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937437813870 EUDAMED
- Basic UDI-DI
- 6972370761200000LP EUDAMED
- EMDN Code
- M020199 COTTON GAUZES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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 balls by Shaoxing Yibon Medical 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 | 6972370761200000LP | Class I | Active |
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Manufacturer
- Manufacturer
- Shaoxing Yibon Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000003378
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 2882ab75-ba12-40d4-8385-dfbfdec21783 61 fields · synced Jun 19, 2026