Vircell, S.L
ES-MF-000004099 · Spain · Granada
Vircell, S.L is registered in the European database on medical devices as a manufacturer, with 157 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: C0005, G/M1007, G/M1015, MBC034, MBC038.
Devices declared under this manufacturer
- AMPLIRUN® INFLUENZA A H1 RNA CONTROL
- AMPLIRUN® INFLUENZA A H5 RNA CONTROL
- AMPLIRUN® MYCOBACTERIUM TUBERCULOSIS DNA CONTROL
- AMPLIRUN® PARAINFLUENZA 2 RNA CONTROL
- AMPLIRUN® RESPIRATORY SYNCYTIAL VIRUS (A) RNA CONTROL
- CHLAMYDOPHILA PNEUMONIAE VIRCLIA® IgG MONOTEST
- HEPATITIS DELTA REALTIME PCR KIT
- IFA IgA FITC-CONJUGATE
- INFLUENZA A ELISA IgG/IgM
- MYCOPLASMA PNEUMONIAE ELISA IgG/IgM
- SARS-CoV-2/FluA/FluB/RSV REAL TIME PCR KIT
- TICK-BORNE ENCEPHALITIS VIRCLIA® IgG MONOTEST
Showing 12 of 157 declared devices.
Catalogue references include C0005, G/M1007, G/M1015, MBC034, MBC041, RTPCR017-LP.
European nomenclature codes declared: W0599, W0105080808, W0105040604, W0105010802, W0105070501, W0105070504.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 157 |
| 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 | 157 |
|---|---|
| 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. Vircell, S.L was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
V76 112727 0006 | issued | 2031-02-22 |
V13 112727 0005 | supplemented | 2027-10-17 |