Identity
- Trade Name
- RDx EUDAMED
- Device Name
- RDx EUDAMED
- Model / Reference
- v2.7 EUDAMEDv2.8 EUDAMEDv2.0 EUDAMEDv2.9 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430078740098 EUDAMED06430078740289 EUDAMED06430078740081 EUDAMED06430078740302 EUDAMED
- Basic UDI-DI
- 6430078740002WY EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Finland 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
RDx by Topcon Healthcare Solutions EMEA Oy — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6430078740002WY | Class I | Active |
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Manufacturer
- Manufacturer
- Topcon Healthcare Solutions EMEA Oy
- EUDAMED SRN
- FI-MF-000004775
Sources (4)
- EUDAMED 576b944f-87ce-4aa9-823e-3f4e015dc683 61 fields · synced Jul 30, 2026
- EUDAMED e938bc6c-465b-4b10-bcc4-894a6327a544 61 fields · synced May 17, 2026
- EUDAMED 9519ee19-8fa6-4cde-8877-ae8e2b87bb40 61 fields · synced May 19, 2026
- EUDAMED ad30faa1-46f9-44d9-95e4-ea9116a751cc 61 fields · synced Jul 8, 2026