Identity
- Device Name
- Oxygen Enrichment Device EUDAMED
- Model / Reference
- 760100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055525406696 EUDAMED
- Basic UDI-DI
- 697253861MOD01LJ EUDAMED
- EMDN Code
- R01038099 ENDOTRACHEAL TUBES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES 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
Oxygen Enrichment Device by Three Lions Limited — 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 | 697253861MOD01LJ | 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 (1)
- EUDAMED 83c43dc6-ec19-44bc-bb67-8b8915e83453 61 fields · synced Jun 19, 2026