Bioxol Kft
HU-MF-000025409 · Hungary · Budapest
Bioxol Kft is registered in the European database on medical devices as a manufacturer, with 158 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: BioClean M22, BioClean SYS, BioDye-NR-eco SYS, BioHypoclean Strong, BioLyse CD 3.
Devices declared under this manufacturer
- BioClean M22 cleaning reagent 1L
- BioClean SYS Cleaning reagent 1L
- BioClean SYS Cleaning reagent 5L
- BioClean cleaning reagent 5L
- BioDil NK diluent 10L
- BioDye-NR-eco SYS NRBC fluorescent dye 3x12mL
- BioHypoclean Strong hypochlorite cleaning reagent 50mL
- BioLyse CD 3 Lysing and hemoglobin reagent 1L
- BioLyse CD 3 Lysing and hemoglobin reagent 5L
- BioLyse M22 WBC-5-diff lysing reagent 0.5L
- BioLyse SW WBC-3-diff lysing reagent 1L
- BioLyse-BASO-2 AX Basophil reagent 1L
Showing 12 of 158 declared devices.
Catalogue references include HY-7009, OM-2061, OM-5061, S024, SW-2151, SY-2020.
European nomenclature codes declared: W0103010105.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 158 |
| Country of registration | Hungary |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 158 |
|---|---|
| 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. Bioxol Kft was not found in either the U.S. or the Canadian register.