Identity
- Trade Name
- Oxi.Plus Nasal Cannula Set, #3 EUDAMED
- Device Name
- Disposable Oxygen therapy EUDAMED
- Model / Reference
- AO0043 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980105982 EUDAMED
- Basic UDI-DI
- 69239801ND2MAPJ EUDAMED
- EMDN Code
- R0301020301 OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Slovenia 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
Oxi.Plus Nasal Cannula Set, #3 by GaleMed (Xiamen) Co., Ltd. — Class IIa — 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 | 69239801ND2MAPJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- GaleMed (Xiamen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020627
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 323eaa00-2ecc-4e5a-a8cb-f858174ca7f1 61 fields · synced Jul 13, 2026