Identity
- Trade Name
- RETINAL CAMERA TRC-50DX EUDAMED
- Device Name
- RETINAL CAMERA TRC-50DX EUDAMED
- Model / Reference
- TRC-50DX EUDAMED1047744-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571130282650 EUDAMED
- Basic UDI-DI
- B-04571130282650 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
Retinal Camera Trc-50dx by Topcon Corporation — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04571130282650 | 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 (1)
- EUDAMED fc4d59fc-16cf-409b-9e4c-e632eba31057 61 fields · synced May 23, 2026