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OxyPAP
EUDAMEDClass IIb (EU MDR)
Ref nice 5060 FModel nice 5060, nice 5060 S, nice 5060 FRef nice 5060 SRef nice 5060
Identity
- Trade Name
- OxyPAP EUDAMED
- Device Name
- Bubble CPAP System EUDAMED
- Model / Reference
- nice 5060, nice 5060 S, nice 5060 F EUDAMEDnice 5060 F EUDAMEDnice 5060 S EUDAMEDnice 5060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908003989051 EUDAMED08908003989044 EUDAMED08908003989037 EUDAMED
- Basic UDI-DI
- 8908003989nice5060LJ EUDAMED
- EMDN Code
- R060202 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
OxyPAP 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 | 8908003989nice5060LJ | 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 (3)
- EUDAMED 78ad51db-766f-45d9-9947-733386316320 61 fields · synced Jul 20, 2026
- EUDAMED 7ca2a811-60fa-41af-9896-666b7c2fd1dc 61 fields · synced May 18, 2026
- EUDAMED 84980504-830e-4a09-9cb7-1829d1f0e50b 61 fields · synced May 19, 2026