VitroBioChem SRL
RO-MF-000010877 · Romania · BUCHAREST
VitroBioChem SRL is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: Clostridium difficile GDH+Toxin A+Toxin B Combo, Rapid Test Cassette (, Enterovirus Ag (feces) cassette Test rapid Enterovirus Ag (din materii, Giardia lamblia Ag (Feces)Rapid Test cassette Test rapid Giardia lambl, HAV IgM Rapid Test Cassette (Serum/ Plasma) Test Rapid HAV IgM (ser/pl, Multi-Line 12 Drugs Rapid Test Cassette (urine) TEST RAPID MULTIDROG 1.
Devices declared under this manufacturer
- Clostridium difficile GDH+Toxin A+Toxin B Combo, Rapid Test Cassette (
- Enterovirus Ag (feces) cassette Test rapid Enterovirus Ag (din materii
- FOB RAPID TEST CASSETTE (FECES), POSITIVE CONTROL SWAB INCLUDED
- Giardia lamblia Ag (Feces)Rapid Test cassette Test rapid Giardia lambl
- HAV IgM Rapid Test Cassette (Serum/ Plasma) Test Rapid HAV IgM (ser/pl
- HELICOBACTER PYLORI AB RAPID TEST CASSETTE (SERUM/PLASMA)
- Multi-Line 12 Drugs Rapid Test Cassette (urine) TEST RAPID MULTIDROG 1
- Multi-Line 18 Drugs (urine) Test Cassette TEST RAPID MULTIDROG 18 PARA
- RSV Ag + Adenovirus Resp. Ag COMBO rapid test cassette (Swab) positive
- Rapid Test Cassette Strep A (Throat Swab) positive and negative contro
- Rotavirus Ag and Adenovirus Ag (Feces) COMBO Rapid Test Cassette Test
- Syphilis (Whole blood /Serum /Plasma) Rapid Test Cassette Test rapid S
Showing 12 of 13 declared devices.
Catalogue references include VT-CDABGDH-25, VT-GIA-25, VT-HAVM-25, VT-HPG-25, VT-MLD12-25, VT-MLD18-25.
European nomenclature codes declared: W0101060399, W01021699, W0102160511, W0105010401, W0105090103, W0105011803.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 13 |
| Country of registration | Romania |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 13 |
|---|---|
| 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. VitroBioChem SRL was not found in either the U.S. or the Canadian register.