Reboocon Bionics B.V.
NL-MF-000000239 · Netherlands · Pijnacker
Reboocon Bionics B.V. is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 5 |
|---|
Among these devices, 5 are declared active.
Devices declared under this manufacturer
- Intuy Knee
- Intuy Knee NEO
- Intuy Knee PRO
- Intuy Knee RISE
Catalogue references include 1K1R, IK1N, IK1P, ILK-1B, ILK-1W.
European nomenclature codes declared: Y062412,Y062415.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | REBOOCON BIONICS B.V. (NL) · FDA 3026078097 |
| Devices in EUDAMED | 5 |
| Country of registration | Netherlands |
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| 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: United States only. Reboocon Bionics B.V. is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
21M00054CRT02 | issued | 2024-12-02 |
21M00054CRT02 | reissued | 2029-12-02 |