GymnaUniphy N.V.
BE-MF-000001786 · Belgium · Bilzen
GymnaUniphy N.V. is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 12 |
|---|
Most frequent device types declared: Device for multiple non-invasive electrophysical modalities, Device for ultrasound therapy, Devices for electrolysis and dry needling, electric treatment table.
Among these devices, 12 are declared active.
Devices declared under this manufacturer
- Acure Electrolysis 8000
- Elexeo Battery pack
- Elexeo Electrotherapy control
- Elexeo Electrotherapy module
- Elexeo Ultrasound control
- Elexeo Ultrasound module
- Elexeo Vaco module
- Gymna Acure 250
- Gymna Ultrasound compact
- gymna.ONE D6
- gymna.ONE Q8
- gymna.ONE T7
Catalogue references include 198062, 198064, 198066 ,198068, 198082, 198084, 198086, 198088, 363100, 370300, 370350, 375180.
European nomenclature codes declared: Z12069099, Z120601.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 12 |
| Country of registration | Belgium |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 12 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | GYMNAUNIPHY N.V. |
What it holds in Canada
| Licences on record | 12 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 12 |
| First licensed | 2008-07-10 |
Licence types: Single Device (6), Device Family (3), System (2), Device Group Family (1).
Licensed under: PULSON 100, PULSON 200, VACO 200 SUCTION ELECTRODES, ULTRASOUND TREATMENT HEADS, DUO 200, COMBI 200.
North American profile: Canada only. GymnaUniphy N.V. holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2257802CE01 | supplemented | 2028-10-01 |