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: GMA & 2-Hema hydrogel contact lens, Gentle Hydrogel Contact lenses, Methafilcon hydrogel lathed contact lens, Silicone Hydrogel lathed contact lens, Silicone Hydrogel moulded contact lens.
Among these devices, 108 are declared sterile.
Devices declared under this manufacturer
- Aera by mark'ennovy SPH 3pk
- Aera by mark'ennovy SPH 6pk
- Blu:kidz MFT
- Blu:kidz Toric
- EDOF 59 Toric
- MYLO
- Quattro TORIC
- SPH5
- Saphir Rx MF Toric
- Xtensa Rx MF
- Xtensa Rx SpH
- delta Hy Sph
Showing 12 of 108 declared devices.
Catalogue references include 08445773220842, 08445773220859, 08445773266062, 10018, 20013, 20022.
European nomenclature codes declared: Q0210040102.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 108 |
| 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 | 90 |
|---|---|
| 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. mark'ennovy Personalized Care S.L. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ES25/00001111 | supplemented | 2030-10-23 |