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Image Filing Software NAVIS-EX
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 19702-0040Model NAVIS-EX
Identity
- Trade Name
- Image Filing Software NAVIS-EX EUDAMED
- Model / Reference
- NAVIS-EX EUDAMED19702-0040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987669101643 EUDAMED
- Basic UDI-DI
- 4987669217GH EUDAMED
- EMDN Code
- Z12120192 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands 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
Image Filing Software NAVIS-EX by Nidek Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181345 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4987669217GH | 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 ccbeb6d6-68e4-4b7b-aa90-ddc505059fcd 61 fields · synced Jul 29, 2026
- FDA 510(k) K181345 1 fields · synced May 18, 2026