Identity
- Trade Name
- Nonsterile Non-woven Face Mask EUDAMED
- Device Name
- Nonsterile Non-woven Face Mask EUDAMED
- Model / Reference
- C011001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 56971872201439 EUDAMED
- Basic UDI-DI
- 6971872201311000LT EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMEDT020699 MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER EUDAMED
Classification
- Device Class
- Class I 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 Non-woven Face Mask 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 | 6971872201311000LT | 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 (2)
- EUDAMED 26374dd2-a852-492e-9aa8-cf38ed134f57 61 fields · synced Jun 18, 2026
- EUDAMED 1be6f1c9-c33e-41e2-8315-dfe38442190b 61 fields · synced Jun 18, 2026