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Retinal Camera Trc-50dx
EUDAMEDClass IIa (EU MDR)
Ref 1047745-03Model TRC-50DXRef TRC-50DX (Type IA)
Identity
- Trade Name
- RETINAL CAMERA TRC-50DX EUDAMED
- Device Name
- RETINAL CAMERA TRC-50DX EUDAMEDRETINAL CAMERA EUDAMED
- Model / Reference
- TRC-50DX EUDAMED1047745-03 EUDAMEDTRC-50DX (Type IA) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571130282667 EUDAMED04571130283503 EUDAMED04571130283497 EUDAMED
- Basic UDI-DI
- B-04571130282667 EUDAMED4560126260020TV 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
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
Retinal Camera Trc-50dx by Topcon Corporation — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04571130282667 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04571130282667 | 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 (3)
- EUDAMED 9b413970-ca8f-472c-99be-308db28231d3 61 fields · synced Jul 26, 2026
- EUDAMED 06965f66-95b0-458b-b5ed-0fadb70a0cd2 61 fields · synced May 16, 2026
- EUDAMED 67a2455b-cb8b-4da4-b96c-722587b204a7 61 fields · synced May 17, 2026