LEDRAPLASTIC SPA
IT-MF-000021280 · Italy · OSOPPO (UD)
LEDRAPLASTIC SPA is registered in the European database on medical devices as a manufacturer, with 75 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 75 |
|---|
Devices declared under this manufacturer
- Aku Ball
- Body Ball 55 BRQ
- Comfort'a'Back
- Disc’o’Sit
- Gymnic Arte 65 BRQ
- Gymnic Classic 65
- Memory Ball 65 BRQ
- Movin' Sit Jr.
- Physio Activity Roll
- Physio Roll 30
- Physio Roll 85
- Sit’n’Gym Jr. 45
Showing 12 of 75 declared devices.
Catalogue references include 88.04, 89.09, 89.11, 89.45, 94.65, 95.36.
European nomenclature codes declared: V0899.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 75 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 75 |
|---|---|
| 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. LEDRAPLASTIC SPA was not found in either the U.S. or the Canadian register.