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Sapphire
EUDAMEDClass IIa (EU MDR)
Ref nice 4000 LEDModel nice 4000 LED, nice 4000 SPOT
Identity
- Trade Name
- Sapphire EUDAMED
- Device Name
- Infant Phototherapy with Accessories EUDAMEDInfant Phototherapy EUDAMED
- Model / Reference
- nice 4000 LED, nice 4000 SPOT EUDAMEDnice 4000 LED EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908003989006 EUDAMED
- Basic UDI-DI
- 08908003989SapphireZE EUDAMEDB-08908003989006 EUDAMED
- EMDN Code
- Z12080401 PAEDIATRIC PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sapphire by nice Neotech Medical Systems Pvt. Ltd., — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 08908003989SapphireZE | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 08908003989SapphireZE | Class IIa | 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 be0af0cb-4473-4a15-abb2-211cae93233e 61 fields · synced Jul 29, 2026
- EUDAMED 80e7c7e0-b511-4a8a-98da-eb14ae8c0064 61 fields · synced May 18, 2026