Identity
- Trade Name
- Sterile Gauze Balls EUDAMED
- Device Name
- Sterile Gauze Balls EUDAMED
- Model / Reference
- Is EUDAMED1450006V EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972370767064 EUDAMED
- Basic UDI-DI
- 697237076YB1SD02SG EUDAMED
- EMDN Code
- M0201020101 COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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 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 | 697237076YB1SD02SG | 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 b95214d8-b1d4-4667-b1ac-fbcf4acf00b3 61 fields · synced Jun 19, 2026