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Optical Coherence Tomography RS-1
EUDAMEDClass IIa (EU MDR)
Ref SA002-0040Model RS-1,Mirante,RS-3000 Advance
Identity
- Trade Name
- Optical Coherence Tomography RS-1 EUDAMED
- Model / Reference
- RS-1,Mirante,RS-3000 Advance EUDAMEDSA002-0040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987669203705 EUDAMED
- Basic UDI-DI
- 4987669216GF EUDAMED
- EMDN Code
- Z12120121,Z12120199 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Optical Coherence Tomography RS-1 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 | 4987669216GF | 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 cd96e1e0-baf4-415d-907c-c47cc8577c9e 61 fields · synced Jul 16, 2026