Roclub GmbH
Active in EUDAMEDGermanyfrom SRN EUDAMED SRN DE-MF-000046379
- Devices
- 2
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Roclub GmbH makes
Roclub GmbH manufactures the rTOP, a medical device designed for transcatheter aortic valve replacement (TAVR) procedures. This device is intended for use in patients with aortic stenosis who are at intermediate or higher surgical risk.
The rTOP is classified as a Class II device under FDA regulations and is authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Company details
- EUDAMED SRN
- DE-MF-000046379
- DUNS number
- 344083004
- EU VAT number
- DE352202538
- EUDAMED status
- Active
- EUDAMED registered name
- roclub GmbH
- EUDAMED abbreviated name
- roclub
- Registered address
- 179-180, Uhlandstraße, 10623, Berlin, Germany
- Website
- www.roclub.com
- [email protected]
- PRRC contact
- Mario Schrenk
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 12 Oct 2030
SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ 1304 1 certificate
- MDR-0031 Active
Quality management system EU MDR
- Issued
- 15 Jul 2026
- Expires
- 12 Oct 2030
- Reason
- Mnf data change
Frequently asked questions
How many devices does Roclub GmbH have in the registry?
The registry currently lists 2 devices for Roclub GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Roclub GmbH's devices?
Among its 2 most recently registered devices, Roclub GmbH has devices listed in EUDAMED (1 device), FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Roclub GmbH's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Roclub GmbH's devices are Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Roclub GmbH?
EUDAMED lists 1 certificate for Roclub GmbH (quality management system) under MDR. The most recent was issued on 15 Jul 2026.
What are the newest devices from Roclub GmbH in the registry?
The most recently registered devices listed for Roclub GmbH include rTOP 1 and rTOP.