Identity
- Trade Name
- Non-woven face mask EUDAMED
- Device Name
- Non-woven face mask EUDAMED
- Model / Reference
- 17.5x9.5cm,2ply,3ply,4ply EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973113121457 EUDAMED
- Basic UDI-DI
- 697311312nwfacemask50Y2 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR 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
Non-woven face mask by Xiamen Ticare Imp.&Exp. 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 | 697311312nwfacemask50Y2 | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Ticare Imp.&Exp. Co., Ltd.
- EUDAMED SRN
- CN-MF-000036083
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 20552d3d-5b4e-4ea6-be79-40ef9ad042d2 61 fields · synced Jul 24, 2026
- EUDAMED 20552d3d-5b4e-4ea6-be79-40ef9ad042d2-1 61 fields · synced Jun 10, 2026