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Medical Face Mask
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref A-31WModel A-31W, A-31B, A-31G A-05W, A-05B, A-05G
Identity
- Device Name
- Medical Face Mask EUDAMED
- Model / Reference
- A-31W, A-31B, A-31G A-05W, A-05B, A-05G EUDAMEDA-31W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973219621004 EUDAMED
- Basic UDI-DI
- 697321962101JL EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR 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
Medical Face Mask by Ammex-Weida (Hubei) Health and Safety Products Co., Ltd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211062 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697321962101JL | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000011701
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 5aa480a8-35c8-4546-bf0f-be0b9ab7709a 61 fields · synced Oct 6, 2026
- FDA 510(k) K211062 1 fields · synced May 18, 2026