Reboocon Bionics B.V.
Active in EUDAMEDNetherlandsfrom SRN EUDAMED FDA SRN NL-MF-000000239 FEI 3026078097
- Devices
- 4
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 2 in force. 1 certificate has expired.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA FEI
Catalogue
Intuy Knee PRO Ref IK1P
Intuy Knee RISE Ref 1K1R
Intuy Knee Ref ILK-1B
Intuy Knee NEO Ref IK1N
Company details
- EUDAMED SRN
- NL-MF-000000239
- FDA FEI number
- 3026078097
- EU VAT number
- NL856594635B01
- EUDAMED status
- Active
- EUDAMED registered name
- Reboocon Bionics B.V.
- Registered address
- 4, Ambachtsweg, 2641KS, Pijnacker, Netherlands
- Website
- rbionics.com
- facebook.com/rebooconbionics
- [email protected]
- Phone
- +31636275861
- PRRC contact
- Shiqian Wang
EUDAMED certificates
2 certificates1 valid, 1 expiredMDR 2next expiry 2 Dec 2029
Notified body 1912 2 certificates
- 24M00080CRT05 Amended
Quality management system EU MDR
- Issued
- 23 Oct 2025
- Expires
- 2 Dec 2029
- Reason
- Other
- 21M00054CRT02 Expired
Quality management system EU MDR
- Issued
- 2 Dec 2021
- Expires
- 2 Dec 2024
What Reboocon Bionics B.V. makes
Reboocon Bionics B.V. manufactures prosthetic knee devices, including the Intuy Knee PRO, Intuy Knee RISE, Intuy Knee, and Intuy Knee NEO.
These devices are classified as Class IIa and are listed in the EUDAMED regulatory registry. The company is based in the Netherlands.
Frequently asked questions
How many devices does Reboocon Bionics B.V. have in the registry?
The registry currently lists 4 devices for Reboocon Bionics B.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Reboocon Bionics B.V.'s devices?
Among its 4 most recently registered devices, Reboocon Bionics B.V. has devices listed in EUDAMED (4 devices).
What risk classes do Reboocon Bionics B.V.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Reboocon Bionics B.V.'s devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Reboocon Bionics B.V.?
EUDAMED lists 2 certificates for Reboocon Bionics B.V. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2025-10-23.
What are the newest devices from Reboocon Bionics B.V. in the registry?
The most recently registered devices listed for Reboocon Bionics B.V. include Intuy Knee PRO, Intuy Knee RISE, Intuy Knee and Intuy Knee NEO.