Enraf-Nonius B.V.
NL-MF-000000429 · Netherlands · Rotterdam
Enraf-Nonius B.V. is registered in the European database on medical devices as a manufacturer, with 50 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 50 |
|---|
Among these devices, 47 are declared active.
Devices declared under this manufacturer
- Bike Reha
- EN-Dynamic Abduction
- EN-Dynamic Back Trainer
- EN-Dynamic Fly
- EN-Dynamic Pull Down
- EN-Dynamic Squat
- EN-Dynamic Total Hip
- EN-Motion
- EN-Tree Bench
- ManuMax
- ManuXelect
- Manumed
Showing 12 of 50 declared devices.
Catalogue references include 1455953, 1455960, 1665901, 3448162, 3448163, MBnnnnnn.
European nomenclature codes declared: Z120602, Z129006, Z120619, Z120610.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ENRAF-NONIUS B.V. (NL) · FDA 9612147 |
| Devices in EUDAMED | 50 |
| Country of registration | Netherlands |
Device-level evidence
| Devices with a numeric GTIN | 50 |
|---|---|
| Found in the U.S. device database | 20 |
| Share | 40.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ENRAF-NONIUS B.V. |
What it holds in Canada
| Licences on record | 12 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 12 |
| First licensed | 2001-10-09 |
Licence types: System (6), Device Family (3), Device Group Family (2), Single Device (1).
Licensed under: SONOPULS 492, ENDOMED 182 ELECTROTHERAPY SYSTEM, VACOTRON 460, ELTRAC 471, ULTRASOUND TREATMENT HEADS, SONOPULS 190.
North American profile: Both markets. Enraf-Nonius B.V. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1274285-1 | issued | 2031-05-03 |