Identity
- Trade Name
- Sterile Gauze Balls EUDAMED
- Device Name
- Sterile Gauze Balls EUDAMED
- Model / Reference
- C103040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971872208365 EUDAMED
- Basic UDI-DI
- 6971872201031001LC EUDAMED
- EMDN Code
- M0201050101 COTTON GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE 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 Balls by Kingstar Medical (Xianning) 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 | 6971872201031001LC | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
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 73a2daf3-2956-4164-8510-50d86247b996 61 fields · synced Jun 18, 2026