Operah Plus
by nice Neotech Medical Systems Pvt. Ltd., 2 variants
Ref nice 5000 P, nice 5000, nice 5000 R
Operah Plus (nice 5000 P) is a medical device (EU MDD Class IIb) made by nice Neotech Medical Systems Pvt. Ltd.,, registered in EUDAMED on 27 Oct 2021 (Basic UDI-DI B-08908003989082), active as of 22 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08908003989082 | Date27 Oct 2021 | StatusActive |
Official records
- EUDAMED public site B-08908003989082
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Trade name
- Operah PlusOperah
- Device name
- Infant Radiant Warmer with PhototherapyInfant Radiant WarmerInfant Radiant Warmer with T-Piece Resuscitator
- Model / reference
- nice 5000 P, nice 5000, nice 5000 R
- Primary DI / UDI-DI
- 08908003989082, 08908003989099, 08908003989068
- Basic UDI-DI
- B-08908003989082, B-08908003989099, B-08908003989068
- EMDN code
- Z12080401, Z12080407, R9099
- Device class
- Class IIb
- System or procedure pack
- System which is a device in itself
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- IN-MF-000010243
- Authorised representative
- Amstermed B.V. NL-AR-000001971
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