Identity
- Trade Name
- Nonsterile X-Ray Detectable Gauze Balls EUDAMED
- Device Name
- Nonsterile X-Ray Detectable Gauze Balls EUDAMED
- Model / Reference
- C003072X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 76936662603446 EUDAMED
- Basic UDI-DI
- 693666261031010RK EUDAMED
- EMDN Code
- M0201050202 COTTON GAUZE PADS, WITH X-RAY DETECTABLE THREAD, NON-STERILE EUDAMED
Classification
- Device Class
- Class IIa 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
Nonsterile X-Ray Detectable Gauze Balls by Kingstar Medical (Xianning) Co., LTD — Class IIa — 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 | 693666261031010RK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kingstar Medical (Xianning) Co., LTD
- EUDAMED SRN
- CN-MF-000006015
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 14684fb9-8510-4d78-ac57-9cadcac9b4e5 61 fields · synced Jun 19, 2026