mark'ennovy Personalized Care S.L.
ES-MF-000001436 · Spain · Madrid
mark'ennovy Personalized Care S.L. is registered in the European database on medical devices as a manufacturer, with 108 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 108 |
|---|
Most frequent device types declared: Gentle Hydrogel Contact lenses, Silicone Hydrogel lathed contact lens, Silicone Hydrogel moulded contact lens, GMA & 2-Hema hydrogel contact lens, Methafilcon hydrogel lathed contact lens .
Among these devices, 108 are declared sterile.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 108 |
| Country of registration | Spain |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ES25/00001111 | supplemented | 2030-10-23 |