Identity
- Trade Name
- Sterile Gauze Balls EUDAMED
- Device Name
- Sterile Gauze Balls EUDAMED
- Model / Reference
- C103129 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936662600682 EUDAMED
- Basic UDI-DI
- 693666261031001RJ 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
Category: Intranasal splint, non-biodegradable
Sterile Gauze Balls by Kingstar Medical (Xianning) Co., LTD — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Intranasal splint, non-biodegradable.
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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 | 693666261031001RJ | Class I | 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 6a934958-3bef-436c-978e-634cdfba0c28 61 fields · synced Jun 18, 2026