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Non-Mydriatic Retinal Camera Trc-Nw8
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 405089701Model TRC-NW8510(k) K130289
Identity
- Trade Name
- NON-MYDRIATIC RETINAL CAMERA TRC-NW8 EUDAMED
- Device Name
- NON-MYDRIATIC RETINAL CAMERA TRC-NW8 EUDAMED
- Model / Reference
- TRC-NW8 EUDAMED405089701 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-JPMF3928_405089701FZ EUDAMED
- Basic UDI-DI
- B-JPMF3928_405089701FZ EUDAMED
- EMDN Code
- Z12120105 FLUOROANGIOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Non-Mydriatic Retinal Camera Trc-Nw8 by Topcon Corporation — Class IIa — FDA_510K, MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130289 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-JPMF3928_405089701FZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Topcon Corporation
- EUDAMED SRN
- JP-MF-000003928
- FDA Applicant
- Topcon Corp.
- Authorised Representative
- Topcon Europe Medical BV NL-AR-000000441
Sources (2)
- EUDAMED 80e4c4f4-f0ee-46e4-9d41-36c32b40144f 85 fields · synced Jun 19, 2026
- FDA 510(k) K130289 1 fields · synced May 18, 2026