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Operah
EUDAMEDClass IIb (EU MDR)
Ref nice 2010 BCModel nice 2010 BC, nice 2010, nice 2007 S
Identity
- Trade Name
- Operah EUDAMED
- Device Name
- Infant Radiant Warmer EUDAMEDInfant Radiant Warmer with accessories EUDAMED
- Model / Reference
- nice 2010 BC EUDAMEDnice 2010 BC, nice 2010, nice 2007 S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908003989259 EUDAMED
- Basic UDI-DI
- B-08908003989259 EUDAMED08908003989Operah7Z EUDAMED
- EMDN Code
- Z12080407 NEONATAL RADIANT WARMERS 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 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-08908003989259 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08908003989259 | 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 98744235-75b1-4dfa-96ab-edd220670bba 61 fields · synced Jul 15, 2026
- EUDAMED 2bfacece-4849-41e6-bf19-1784bacd90b8 61 fields · synced May 17, 2026