UFSK-International OSYS GmbH
Active in EUDAMEDGermanyfrom SRN EUDAMED FDA SRN DE-MF-000013511 FEI 3004438145
- Devices
- 25
- Registrations
- EUDAMEDFDA
- FDA recalls
- 11 ongoing
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
Catalogue
Search and filter all 25 devicesCompany details
- EUDAMED SRN
- DE-MF-000013511
- FDA FEI number
- 3004438145
- DUNS number
- 332808919
- EU VAT number
- DE232257366
- EUDAMED status
- Active
- EUDAMED registered name
- UFSK-International OSYS GmbH
- EUDAMED abbreviated name
- UFSK-OSYS
- Registered address
- 1, Kirchhoffstraße, 93055, Regensburg, Germany
- Website
- www.ufsk-osys.com
- [email protected]
- Phone
- +49 9 417 88 62 15
- PRRC contact
- Jürgen Scherrieble
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 1
- 2024 0
- 2025 0
- 2026 0
2023
- 31 May 2023 Z-2212-2023 Class II Ongoing Service life of the electrical seat part drive of the treatment chair may be shortened unexpectedly after several years of use due to a potential wear-related reduction in the self-locking of the drive and may remain undetected. A worsened self-locking of the seat drive can lead to overriding the drive s end position when positioning the patient with the seat part in an inclined position
From the company website
The mobile treatment beds of UFSK-International OSYS ensure efficient surgical management and create optimal working conditions for your staff.
Frequently asked questions
How many devices does UFSK-International OSYS GmbH have in the registry?
The registry currently lists 25 devices for UFSK-International OSYS GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list UFSK-International OSYS GmbH's devices?
Among its 25 most recently registered devices, UFSK-International OSYS GmbH has devices listed in EUDAMED (25 devices) and FDA GUDID (22 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do UFSK-International OSYS GmbH's devices fall under?
Among its 25 most recently registered devices, the classes recorded for UFSK-International OSYS GmbH's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for UFSK-International OSYS GmbH?
FDA recall records list 1 recall initiated by UFSK-International OSYS GmbH, the most recent initiated on 31 May 2023. 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 UFSK-International OSYS GmbH in the registry?
The most recently registered devices listed for UFSK-International OSYS GmbH include assistPure, surgiForce with comfort seat, 400 XL and assistPro F.