IMMUNOTECH s.r.o.
CZ-MF-000001761 · Czechia · Prague 10
IMMUNOTECH s.r.o. is registered in the European database on medical devices as a manufacturer, with 93 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: IM2121, IM3303, IM2233, B64312, Immunoassay A21854, Immunoassay IM1188, Immunoassay IM1699, IM3287.
Devices declared under this manufacturer
- Anti-TPO RIA KIT
- FT4 RIA KIT
- Ferritin IRMA KIT
- IRMA CA 125 antigen
- IRMA PTH
- Inhibin B Gen II Calibrators and Controls
- Ostase IRMA KIT
- Prolactin IRMA KIT
- RIA Aldosterone
- RIA Estradiol
- RIA Progesterone
- RIA Testosterone, direct
Showing 12 of 93 declared devices.
Catalogue references include A21854, B89462, A44176, A56719, B89461, IM1699, IM3287, IM2121.
European nomenclature codes declared: W0102039099, W01020405, W01020402, W0102050110, W0102050103, W0102060312.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | IMMUNOTECH s.r.o. (CZ) · FDA 3003385757 |
| Devices in EUDAMED | 93 |
| Country of registration | Czechia |
Device-level evidence
| Devices with a numeric GTIN | 93 |
|---|---|
| Found in the U.S. device database | 7 |
| Share | 7.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | IMMUNOTECH S.R.O. |
What it holds in Canada
| Licences on record | 14 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 14 |
| First licensed | 2005-04-08 |
Licence types: Test Kit (13), Device Family (1).
Licensed under: ULTRA-SENSITIVE ESTRADIOL RIA, ACTIVE IGFBP-3 IRMA, DEHYDROEPIANDROSTERONE (DHEA) RIA, ACTIVE ANDROSTENEDIONE RIA, ACTIVE ALDOSTERONE RIA, ESTRONE RIA.
North American profile: Both markets. IMMUNOTECH s.r.o. is registered in both the United States and Canada.