CERTEST BIOTEC S.L.
ES-MF-000002193 · Spain · SAN MATEO DE GALLEGO (ZARAGOZA)
CERTEST BIOTEC S.L. is registered in the European database on medical devices as a manufacturer, with 852 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: VIASURE Mycoplasma genitalium with Macrolide Resistance Assay for BD M.
Devices declared under this manufacturer
- CerTest Astrovirus
- CerTest Rotavirus+Adenovirus+Astrovirus
- Universal Turbilatex® Sample Vial
- VIASURE BK virus q Real Time PCR Detection Kit
- VIASURE H. influenzae, S. pneumoniae & M. catarrhalis Real Time PCR De
- VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection
- VIASURE Herpes virus 1, Herpes virus 2 & Varicella Zoster Virus Real T
- VIASURE Human Herpes Virus 6, 7 & 8 Real Time PCR Detection Kit
- VIASURE Monkeypox virus Real Time PCR Detection Kit
- VIASURE Neisseria gonorrhoeae ciprofloxacin resistant Real Time PCR De
- VIASURE RSV A + B Real Time PCR Detection Kit
- VIASURE Rhinovirus + Enterovirus Real Time PCR Detection Kit
Showing 12 of 852 declared devices.
Catalogue references include RT872001VC, RT872001VCC, VS-BKQ112L, VS-CLA196T, VS-NCR101LE, VS-NCR113HE.
European nomenclature codes declared: W0105070503, W0105040599, W0105040504, W0105050399, W0105099099, W0105070504.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 852 |
| Country of registration | Spain |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 852 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | CERTEST BIOTEC S.L. |
What it holds in Canada
| Licences on record | 9 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 9 |
| First licensed | 2024-11-04 |
Licence types: Device Family (9).
Licensed under: VIASURE BLASTOCYSTIS HOMINIS + DIENTAMOEBA FRA, VIASURE CRYPTOSPORIDIUM, GIARDIA AND E. HISTO, VIASURE C. PNEUMONIAE, M. PNEUMONIAE & L. PNEU, VIASURE ASPERGILLUS DIFFERENTIATION REAL TIME , VIASURE MALARIA DIFFERENTIATION REAL TIME PCR , VIASURE PNEUMOCYSTIS JIROVECII REAL TIME PCR D.
North American profile: Canada only. CERTEST BIOTEC S.L. holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HX 1973122-1 | supplemented | 2029-12-18 |