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Sign in to claim this brandTatraMed Software s.r.o.
Slovakia·SK-MF-000017681
Last updated September 17, 2026
About
Tatramed has a fixed market position, including thanks to the long-term high level of service provided. We operate in the field of medical informatics and focus on the development of diagnostic and therapeutic software systems.
Translated from the manufacturer's own website. Source
What TatraMed Software s.r.o. makes
TatraMed Software develops diagnostic and therapeutic software systems, including cone-beam computed tomography (CBCT) analysis tools like the TomoCon GO series (versions 1.0 through 5.0) and related imaging software such as TomoCon PACS. Their products support dental and medical imaging workflows, enabling 3D reconstruction and analysis of radiographic data.
The company’s software portfolio is classified under EU Medical Device Regulations as Class I, Class IIa, and Class IIb devices, with all relevant products listed in the EUDAMED database. TatraMed Software is based in Slovakia.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does TatraMed Software s.r.o. manufacture or develop?
TatraMed Software s.r.o. specializes in developing diagnostic and therapeutic software systems. Their portfolio includes cone-beam computed tomography (CBCT) analysis tools, such as the TomoCon GO series (versions 1.0 through 5.0), as well as related imaging software like TomoCon PACS. These products are designed to support dental and medical imaging workflows, enabling 3D reconstruction and analysis of radiographic data.
Where is TatraMed Software s.r.o. based?
TatraMed Software s.r.o. is based in Slovakia. The company’s location is relevant for understanding its regulatory and operational context within the European Union.
Are TatraMed Software’s devices listed in any regulatory registries?
Yes, TatraMed Software’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. Listing in EUDAMED confirms the devices’ presence in the regulatory system, though it does not imply approval or clearance.
How are TatraMed Software’s devices classified under EU regulations?
TatraMed Software’s devices are classified under the EU Medical Device Regulations as Class I, Class IIa, and Class IIb. Classification determines the regulatory requirements for each device, with higher classes (e.g., Class IIb) typically requiring more rigorous scrutiny due to increased risk.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Slovakia
- Address
- 9, Líčšie údolie, Bratislava, Slovakia
- Website
- www.tatramed.sk
- —
- —
- [email protected]
- Phone
- +421 2 6020 2301
- PRRC Contact
- Ján Hanzel
- EUDAMED SRN
- SK-MF-000017681
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TomoCon GO 5.0 | TomoCon GO 5.0 | EUDAMED | Class IIa | Active |
| TomoCon GO 4.0 | TomoCon GO 4.0 | EUDAMED | Class IIa | Active |
| RTmedes 1.6 | RTmedes - Build: 1.6.21168.1 | EUDAMED | Class I | Active |
| TomoCon GO - versions 1.0, 2.0, 2.1, 2.2, 2.3, 2.4 | TomoCon GO | EUDAMED | Class I | Active |
| TomoCon PACS | TomoCon PACS & Diagnostic stations | EUDAMED | Class IIb | Active |
| TomoCon GO 3.0 | TomoCon GO 3.0 | EUDAMED | Class IIa | Active |
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