BIOTICAL HEALTH S.L.U
ES-MF-000018831 · Spain · SAN FERNANDO DE HENARES
BIOTICAL HEALTH S.L.U is registered in the European database on medical devices as a manufacturer, with 117 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: biotical C. difficile GDH Positive control (1u) / 1 control positivo C, biotical C. difficile Toxin B Positive control (1u) /, biotical Calprotectin Card / 25 test rápidos con viales para muestra f, biotical FOB Card ( +PC +NC) / 25 test rápidos con viales para muestra, biotical Lactoferrin Positive control (1u) / 1 control positivo Lactof.
Among these devices, 3 are declared sterile.
Devices declared under this manufacturer
- biotical C. difficile GDH Positive control (1u)
- biotical C. difficile Toxin B Positive control (1u)
- biotical Calprotectin + Lactoferrin Card (+PC +NC)
- biotical Calprotectin Card
- biotical E. Coli O157:H7 Card
- biotical FOB Card ( +PC +NC)
- biotical Giardia Card (+PC)
- biotical Lactoferrin Positive control (1u)
- biotical Norovirus Gen I + II Card
- biotical Norovirus Gen I + II Card (+PC +NC)
- biotical Rotavirus + Adenovirus Card
- biotical Rotavirus Positive control (30u)
Showing 12 of 117 declared devices.
Catalogue references include CPRT01GD, CPRT01TB, CPRT01Y3, CPRT30R, CPRT30TF, RTB25CP.
European nomenclature codes declared: W0105094001, W0105090199, W0105099099, W0102160199, W0102160801, W0105090499.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 117 |
| 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 | 117 |
|---|---|
| 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. BIOTICAL HEALTH S.L.U was not found in either the U.S. or the Canadian register.