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Fully Assisted Refraction System FARS
EUDAMEDClass IIa (EU MDR)
Ref RTP15-0A40Model FARS
Identity
- Trade Name
- Fully Assisted Refraction System FARS EUDAMED
- Model / Reference
- FARS EUDAMEDRTP15-0A40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987669203552 EUDAMED
- Basic UDI-DI
- 4987669233GF EUDAMED
- EMDN Code
- Z12129092 VARIOUS OPHTALMOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
Fully Assisted Refraction System FARS by Nidek Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4987669233GF | Class IIa | Active |
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Manufacturer
- Manufacturer
- NIDEK.CO.Ltd.,
- EUDAMED SRN
- JP-MF-000040151
- Authorised Representative
- NIDEK SA FR-AR-000000341
Sources (1)
- EUDAMED 030a5bdc-5514-4951-a582-c962636d0ce1 61 fields · synced Jul 11, 2026