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Seefar
EUDAMEDClass IIa (EU MDR)
Ref nice 4000 SPOTModel nice 4000 LED, nice 4000 SPOT
Identity
- Trade Name
- SEEFAR EUDAMED
- Device Name
- Infant Phototherapy EUDAMEDInfant Phototherapy with Accessories EUDAMED
- Model / Reference
- nice 4000 SPOT EUDAMEDnice 4000 LED, nice 4000 SPOT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908003989013 EUDAMED
- Basic UDI-DI
- B-08908003989013 EUDAMED08908003989SapphireZE 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
Seefar by nice Neotech Medical Systems Pvt. Ltd., — Class IIa — 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-08908003989013 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08908003989013 | 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 d2cfb8d3-b9f5-4066-9fcb-fb5ddac813b0 61 fields · synced Jun 18, 2026
- EUDAMED b448754d-3fd5-4376-97ab-aa581262c581 61 fields · synced May 19, 2026