Data / Medical devices / Germany / Roclub GMBH
Roclub GMBH: FDA-registered device maker in Berlin, Germany, 1 510(k) clearance
Roclub GMBH is registered with the FDA (registration 3038189169) in Berlin, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 4, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3038189169
- Address
- Uhlandstrasse, Berlin, Germany, 10623
- Owner or operator
- roclub GmbH (10092986)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 13, 2025
- Registered through
- 2026
- Brand names listed
- rTOP
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 4, 2025 | K243333 | rTOP | LLZ | Substantially Equivalent | Roclub GmbH | accessdata.fda.gov |
Compare with other makers
Updated February 4, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.