PURTEX s.r.o.
CZ-MF-000053672 · Czechia · Zdiby
PURTEX s.r.o. is registered in the European database on medical devices as a manufacturer, with 20 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 20 |
|---|
Most frequent device types declared: ANDEMA CLASSIC, Elegans, VIA.
Devices declared under this manufacturer
- ANDEMA CLASSIC
- Elegans
- VIA
Showing 12 of 20 declared devices.
Catalogue references include 200082954, 200088820, 200089100, 200089278, 200092038, 200096198.
European nomenclature codes declared: V080702, V08030102.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | PURTEX S.R.O. (CZ) · FDA 3038188186 |
| Devices in EUDAMED | 20 |
| Country of registration | Czechia |
Device-level evidence
| Devices with a numeric GTIN | 20 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. PURTEX s.r.o. is registered in the United States but was not found in the Canadian register.