Identity
- Trade Name
- RTmedes 1.6 EUDAMED
- Device Name
- RTmedes EUDAMED
- Model / Reference
- RTmedes - Build: 1.6.21168.1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08588008910016 EUDAMED
- Basic UDI-DI
- 8588008910-RTmedes-PA EUDAMED
- EMDN Code
- Z119092 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Slovakia 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
RTmedes 1.6 by TatraMed Software s.r.o. — 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 | 8588008910-RTmedes-PA | Class I | Active |
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Manufacturer
- Manufacturer
- TatraMed Software s.r.o.
- EUDAMED SRN
- SK-MF-000017681
Sources (1)
- EUDAMED 33371ecf-2dae-4c94-b8e1-d4f11c740240 61 fields · synced Jun 19, 2026