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EYE CARE CARD R/W EyeCa-RW2
EUDAMEDClass I (EU MDR)
Ref 32196-0500,34085-06A2,34085-06B2Model EyeCa-RW2
Identity
- Trade Name
- EYE CARE CARD R/W EyeCa-RW2 EUDAMED
- Model / Reference
- EyeCa-RW2 EUDAMED32196-0500,34085-06A2,34085-06B2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987669101728 EUDAMED
- Basic UDI-DI
- 4987669107G9 EUDAMED
- EMDN Code
- Y2199 COMMUNICATION AND INFORMATION MANAGEMENT AIDS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
EYE CARE CARD R/W EyeCa-RW2 by Nidek Co., Ltd. — Class I — 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 | 4987669107G9 | Class I | 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 529bc5b6-f143-4a1a-8f3e-f4bef58d2117 61 fields · synced Jul 8, 2026
- EUDAMED 529bc5b6-f143-4a1a-8f3e-f4bef58d2117-1 61 fields · synced Jun 9, 2026