Identity
- Trade Name
- Operah EUDAMED
- Device Name
- Infant Radiant Warmer EUDAMED
- Model / Reference
- nice 2010 B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908003989266 EUDAMED
- Basic UDI-DI
- B-08908003989266 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
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 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-08908003989266 | 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 (1)
- EUDAMED 0458fd06-54bd-4117-81bb-822defeb6e0d 61 fields · synced Jun 18, 2026