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Face Mask
EUDAMEDClass I (EU MDR)
Ref Non-woven Face MaskModel Non-woven Face Mask, Medical Masks, Disposable Civilian Face Masks, or Customized
Identity
- Device Name
- Face Mask EUDAMED
- Model / Reference
- Non-woven Face Mask, Medical Masks, Disposable Civilian Face Masks, or Customized EUDAMEDNon-woven Face Mask EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979835250482 EUDAMED
- Basic UDI-DI
- 697983525FaceMaskRN EUDAMED
- EMDN Code
- T020699 MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Face Mask by Yiwu Samo Medical Equipment 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 | 697983525FaceMaskRN | Class I | Active |
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Manufacturer
- Manufacturer
- Yiwu Samo Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000051538
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 845c4748-19b7-4a59-8891-1b9cba169b00 61 fields · synced Oct 6, 2026