← Back to catalogue
Operah Plus
EUDAMEDClass IIb (EU MDR)
Ref nice 5000 PRef nice 5000 Model nice 5000Ref nice 5000 R
Identity
- Trade Name
- Operah Plus EUDAMEDOperah EUDAMED
- Device Name
- Infant Radiant Warmer with Phototherapy EUDAMEDInfant Radiant Warmer EUDAMEDInfant Radiant Warmer with T-Piece Resuscitator EUDAMED
- Model / Reference
- nice 5000 P EUDAMEDnice 5000 EUDAMEDnice 5000 R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908003989082 EUDAMED08908003989099 EUDAMED08908003989068 EUDAMED
- Basic UDI-DI
- B-08908003989082 EUDAMEDB-08908003989099 EUDAMEDB-08908003989068 EUDAMED
- EMDN Code
- Z12080401,Z12080407 EUDAMEDZ12080407 NEONATAL RADIANT WARMERS EUDAMEDR9099,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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08908003989082 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- nice Neotech Medical Systems Pvt. Ltd.,
- EUDAMED SRN
- IN-MF-000010243
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (3)
- EUDAMED c9ac3c70-dda2-4278-8d22-afc0ca639aaa 61 fields · synced Sep 18, 2026
- EUDAMED aea7137b-9440-4961-ad7f-1ab8861792fc 61 fields · synced May 17, 2026
- EUDAMED 79c49c53-b51a-4138-9ce9-1b0c45a3c33d 61 fields · synced May 18, 2026