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Non-Mydriatic Retinal Camera Nw500
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref NW500510(k) K221111
Identity
- Trade Name
- NON-MYDRIATIC RETINAL CAMERA NW500 EUDAMEDFDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- RETINAL CAMERA EUDAMED
- Model / Reference
- NW500 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560126268204 EUDAMED04571130283152 EUDAMEDFDA UDI
- Basic UDI-DI
- 4560126260020TV EUDAMED
- FDA Product Code
- HKI FDA UDI
- EMDN Code
- Z12120105 FLUOROANGIOGRAPHS EUDAMED
- GMDN Term
- Ophthalmic fundus camera FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1120 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Non-Mydriatic Retinal Camera Nw500 by Topcon Corporation — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, 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 | K221111 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4560126260020TV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Topcon Corporation
- EUDAMED SRN
- JP-MF-000003928
- Authorised Representative
- Topcon Europe Medical BV NL-AR-000000441
Sources (4)
- EUDAMED 8f09b2c8-4939-4359-922d-d450ad034465 85 fields · synced Jul 23, 2026
- FDA UDI 273cfaf1-ed1f-472e-8af6-8c0c3e5800ec 32 fields · synced May 30, 2026
- EUDAMED 74a12926-9e4b-4c25-8338-4fa21832333f 61 fields · synced Jul 23, 2026
- FDA 510(k) K221111 1 fields · synced May 18, 2026