Identity
- Trade Name
- TomoCon GO 5.0 EUDAMED
- Device Name
- TomoCon GO EUDAMED
- Model / Reference
- TomoCon GO 5.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08588008910054 EUDAMED
- Basic UDI-DI
- 8588008910-TomoConGO-DA EUDAMED
- Direct Marketing DI
- 08588008910054 EUDAMED
- EMDN Code
- Z11069005 DIAGNOSTIC IMAGING WORKSTATIONS EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Tissue specimen x-ray system IVD
TomoCon GO 5.0 by TatraMed Software s.r.o. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Tissue specimen x-ray system IVD.
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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-TomoConGO-DA | Class IIa | Active |
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Manufacturer
- Manufacturer
- TatraMed Software s.r.o.
- EUDAMED SRN
- SK-MF-000017681
Sources (1)
- EUDAMED b945d46f-742c-4da5-abf6-ee5686d8ab8e 61 fields · synced Jun 18, 2026