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TomoCon PACS
EUDAMEDClass IIb (EU MDR)
Ref TomoCon PACS & Diagnostic stationsModel TomoCon PACS - versions: 25; 24; 23; 22; 21; 20; 19; 18.
Identity
- Trade Name
- TomoCon PACS EUDAMED
- Device Name
- TomoCon PACS EUDAMED
- Model / Reference
- TomoCon PACS - versions: 25; 24; 23; 22; 21; 20; 19; 18. EUDAMEDTomoCon PACS & Diagnostic stations EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-TomoCon-GL EUDAMED
- Basic UDI-DI
- B-TomoCon-GL EUDAMED
- EMDN Code
- Z11030592,Z110603,Z11069005 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Slovakia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
TomoCon PACS by TatraMed Software s.r.o. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-TomoCon-GL | Class IIb | Active |
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Manufacturer
- Manufacturer
- TatraMed Software s.r.o.
- EUDAMED SRN
- SK-MF-000017681
Sources (1)
- EUDAMED 0e4e359f-805a-49c7-97ce-385f563a3d72 61 fields · synced Jul 12, 2026