Identity
- Device Name
- Face Mask EUDAMED
- Model / Reference
- 200xxx EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055525401455 EUDAMED05055525401486 EUDAMED
- Basic UDI-DI
- 697253861MSK01NH EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
Classification
- Device Class
- Class I 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
Category: Anaesthesia face mask, single-use
Face Mask by Three Lions Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697253861MSK01NH | Class I | Active |
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Manufacturer
- Manufacturer
- Three Lions Limited
- EUDAMED SRN
- CN-MF-000027599
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 4d39f41b-6349-4720-aa7e-daa82521dac6 61 fields · synced Jul 19, 2026
- EUDAMED 110f9460-623c-42d6-8ac0-2ff4626dedc3 61 fields · synced May 19, 2026