Identity
- Trade Name
- Operah Plus EUDAMED
- Device Name
- Infant Radiant Warmer with T-Piece Resuscitator and Phototherapy EUDAMEDInfant Radiant Warmer with T-piece Resuscitator, Phototherapy and Accessories EUDAMED
- Model / Reference
- nice 5000 RP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908003989075 EUDAMED
- Basic UDI-DI
- B-08908003989075 EUDAMED08908003989OperahplusTW EUDAMED
- EMDN Code
- R9099,Z12080401,Z12080407 EUDAMEDR03020201,Z12080401,Z12080407 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye 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
Operah Plus by nice Neotech Medical Systems Pvt. Ltd., — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08908003989075 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08908003989075 | 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 72245639-fe66-4b7b-afa4-909e06f65284 61 fields · synced Jul 12, 2026
- EUDAMED 7dba670e-0489-4da0-a958-ae2d7bf58475 61 fields · synced May 19, 2026