SKALAB s.r.o.
CZ-MF-000029744 · Czechia · Svitavy
SKALAB s.r.o. is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- Elektrolyt ECT 1000
- HbA1C Hemolysis G8
- HbA1C Hemolysis, 1 x 1000 ml
- HbA1C Hemolysis, 100 x 1 ml, M
- HbA1C Hemolysis, 100 x 1 ml, Z
- Hemolyzační promývací roztok 90 H, 100 x 1 ml, Z
- ISE PUFR, 1 x 5000 ml
- Koncentrovaný promývací roztok pro osmometry
- Kyvetový blank
- Promývací roztok pro analyzátory Adams A1c
- RAC Cleanser 500
- Solution wash cuvette CZ
Showing 12 of 24 declared devices.
Catalogue references include 08-118432 G8, B 01-4171-58, P 012.01, P 012.02.M, P 012.02.Z, P 114.500.
European nomenclature codes declared: W01019099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 24 |
| 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 | 24 |
|---|---|
| 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. SKALAB s.r.o. was not found in either the U.S. or the Canadian register.