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OxyM
EUDAMEDClass IIb (EU MDR)
Ref nice 5005Model nice 5005, nice 5010Ref nice 5010
Identity
- Trade Name
- OxyM EUDAMED
- Device Name
- Air Oxygen Blender EUDAMED
- Model / Reference
- nice 5005, nice 5010 EUDAMEDnice 5005 EUDAMEDnice 5010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908003989228 EUDAMED08908003989235 EUDAMED
- Basic UDI-DI
- 8908003989nice5010L3 EUDAMED
- EMDN Code
- V0903 CLINICAL/THERAPEUTIC APPLICATIONS GAS MIXTURES EUDAMEDR060202 OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb 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
OxyM by nice Neotech Medical Systems Pvt. Ltd., — Class IIb — 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 | 8908003989nice5010L3 | Class IIb | Active |
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Manufacturer
- Manufacturer
- nice Neotech Medical Systems Pvt. Ltd.,
- EUDAMED SRN
- IN-MF-000010243
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (2)
- EUDAMED dfe9edaa-25dc-420d-b5d1-07a192f27076 61 fields · synced Jul 16, 2026
- EUDAMED ec4cd825-ff21-4913-9a45-a89bc0eb5868 61 fields · synced May 18, 2026