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Optical Coherence Tomography RS-330
EUDAMEDClass IIa (EU MDR)
Ref 10706-0040, 10706-0F40Model RS-330
Identity
- Trade Name
- Optical Coherence Tomography RS-330 EUDAMED
- Model / Reference
- RS-330 EUDAMED10706-0040, 10706-0F40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987669101100 EUDAMED
- Basic UDI-DI
- 4987669218GK EUDAMED
- EMDN Code
- Z12120121,Z12120199 EUDAMED
Classification
- Device Class
- Class IIa 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
Optical Coherence Tomography RS-330 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 | 4987669218GK | 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 (2)
- EUDAMED 0af219b6-1adc-4671-8d4a-e9899e5715c8 61 fields · synced Jul 26, 2026
- EUDAMED 0af219b6-1adc-4671-8d4a-e9899e5715c8-1 61 fields · synced Jun 10, 2026