Identity
- Trade Name
- Face Mask EUDAMED
- Device Name
- Face Mask EUDAMED
- Model / Reference
- MD2001 EUDAMEDMD2002 EUDAMEDMD2004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975549102000 EUDAMED06975549102079 EUDAMED06975549100044 EUDAMED
- Basic UDI-DI
- 697554910004MA EUDAMED
- EMDN Code
- T020699 MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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 Medex International 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 | 697554910004MA | Class I | Active |
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Manufacturer
- Manufacturer
- Medex International Ltd
- EUDAMED SRN
- CN-MF-000034328
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED 9dc48a3c-98a6-4aac-a67a-f9674c8bfdf4 61 fields · synced Jul 10, 2026
- EUDAMED 9c50bcdd-ac99-49cc-b415-640e6e959174 61 fields · synced May 18, 2026
- EUDAMED abfd078e-03d3-4711-b7cc-a9611630c729 61 fields · synced May 19, 2026