ORMESA S.r.l.
IT-MF-000034824 · Italy · Foligno
ORMESA S.r.l. is registered in the European database on medical devices as a manufacturer, with 598 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 598 |
|---|
Most frequent device types declared: BIKO, BUG, DYNAMICO, GRILLO ADAPTIVE SEATING - CHAIR, GRILLO GAIT TRAINER.
Devices declared under this manufacturer
- ADJUSTABLE TROLLI 40 NERO +951+823
- BIKO MEDIUM VERD.864 DIFF.RUOTA LIB
- BIKO SMALL BLU DIFF.RUOTA LIBERA
- BIKO SMALL ROSSO DIFFERENZ.SWITCH
- BIKO XL VERD.DIFF.CAMBIO+CONTROP
- GRILLO ADAPTIVE SEATING BLU mis. SMALL con 863 poggiatesta posturale
- GRILLO ADAPTIVE SEATING ROSSO mis. mini con 863 poggiatesta posturale
- GRILLO ADAPTIVE SEATING with LOWER BASE, PINK size MINI with 865 padde
- GRILLO MED.ANT.PT IBR(PELV.S)
- JUDITTA-36 B12, TAPPEZZERIA GRIGIO CHIARO E TELAIO NERO
- JUDITTA-36 B30, TAPPEZZERIA GRIGIO SCURO E TELAIO NERO
- JUDITTA-40 B60, TAPPEZZERIA GRIGIO CHIARO E TELAIO NERO
Showing 12 of 598 declared devices.
Catalogue references include 05, 29, 46, 47, 62, 65.
European nomenclature codes declared: Y180918, Y121806, Y180939, Y122103, Y050201, Y050202.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ORMESA S.R.L. (IT) · FDA 3003718149 |
| Devices in EUDAMED | 598 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 598 |
|---|---|
| Found in the U.S. device database | 345 |
| Share | 57.7 % |
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: United States only. ORMESA S.r.l. is registered in the United States but was not found in the Canadian register.