i+Med S.Coop.
ES-MF-000008633 · Spain · Vitoria-Gasteiz
i+Med S.Coop. is registered in the European database on medical devices as a manufacturer, with 54 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 22 |
|---|---|
| Class I | 24 |
| Class IIb | 8 |
Most frequent device types declared: BtHCROSS 1.5%, BtHCROSS 2.0%, BtHLINE 1.4%, DayDrop 15ud x 0.4ml, DayDrop 30ud x 0.4ml.
Among these devices, 35 are declared sterile, 27 implantable.
Devices declared under this manufacturer
- BtHCROSS 1.5%
- BtHCROSS 2.0%
- BtHLINE 1.4%
- DayDrop 15ud x 0.4ml
- DayDrop 30ud x 0.4ml
- OpHLINE 1.4%
- OpHLINE 2.0%
- Profilm Aftas Bucales (5ml)
- Profilm Aftas Bucales (5ml) AD
- Profilm Aphtes AD (10mL)
- Profilm Aphtes AR (10mL)
- Profilm Boutons de Fièvre
Showing 12 of 54 declared devices.
Catalogue references include PV00016, PV00025, PV00028, PV00030, PV00040, PV00046.
European nomenclature codes declared: P900402, M04040501, Q02030301, Q02030206.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 54 |
| 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 | 54 |
|---|---|
| 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. i+Med S.Coop. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2026 DR 0071 | issued | 2029-06-26 |
2024 CR 0029 | issued | 2029-06-26 |