Motek Medical B.V.
Active in EUDAMEDNetherlandsfrom SRN EUDAMED FDA SRN NL-MF-000010803 FEI 3006750942
- Devices
- 6
- Registrations
- EUDAMEDFDA
- FDA recalls
- 10 ongoing since 2021 (1 open in total)
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
Catalogue
C-Mill VR+ Ref SY012
Regimes: CE MDR Registry: EUDAMEDGRAIL with 250cm high projection screen Ref SY020
Regimes: CE MDR Registry: EUDAMEDM-GAIT BASE CARENtop Ref SY001
Regimes: CE MDR Registry: EUDAMEDGRAIL with 290cm high projection screen Ref SY020
Regimes: CE MDR Registry: EUDAMEDM-Gait Base Fps Ref SY001
Regimes: CE MDR Registry: EUDAMEDM-Gait Base SA Ref SY001
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- NL-MF-000010803
- SRN (system / procedure pack)
- NL-PR-000013775
- FDA FEI number
- 3006750942
- EU VAT number
- NL8174.55.383.B01
- EUDAMED status
- Active
- EUDAMED registered name
- Motek Medical B.V.
- EUDAMED abbreviated name
- Motek
- Registered address
- 14, Vleugelboot, 3991 CL, Houten, Netherlands
- Website
- www.motekmedical.com
- [email protected]
- Phone
- +31(0)88 6334200
- PRRC contact
- Roland Smit
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 1
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 29 Jul 2019 Z-2135-2020 Class II Open since 2019 The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detaching from the cable guide.
Full distribution text
- 29 Jul 2019 Z-2135-2020 Class II Open since 2019 The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detaching from the cable guide.
From the company website
Motek is setting new standards for human movement research and treatment, bringing together advanced medical technology and virtual reality to change lives.
Frequently asked questions
How many devices does Motek Medical B.V. have in the registry?
The registry currently lists 6 devices for Motek Medical B.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Motek Medical B.V.'s devices?
Among its 6 most recently registered devices, Motek Medical B.V. has devices listed in EUDAMED (6 devices).
What risk classes do Motek Medical B.V.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Motek Medical B.V.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Motek Medical B.V.?
FDA recall records list 1 recall initiated by Motek Medical B.V., the most recent initiated on 29 Jul 2019. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Motek Medical B.V. in the registry?
The most recently registered devices listed for Motek Medical B.V. include C-Mill VR+, GRAIL with 250cm high projection screen, M-GAIT BASE CARENtop and GRAIL with 290cm high projection screen.