SITIN LAB s.r.o.
CZ-MF-000023036 · Czechia · Zdechovice
SITIN LAB s.r.o. is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 11 |
|---|
Devices declared under this manufacturer
- GEMINI ALPHA
- GEMINI AZO
- GEMINI LS
- GEMINI SPIN VS
- GEMINI SPIN VSC
- GEMINI TWIN L
- GEMINI TWIN M
- GEMINI TWIN S
Catalogue references include K-231001-000-X, K-231002-000-X, K-231004-000, K-231005-003-V, K-231005-004, K-231005-004-V.
European nomenclature codes declared: Y122499, V08030102.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 11 |
| Country of registration | Czechia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 11 |
|---|---|
| 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: Neither register. SITIN LAB s.r.o. was not found in either the U.S. or the Canadian register.