Data / Medical devices / Germany / Bebig Medical GMBH
Bebig Medical GMBH: FDA-registered device maker in Berlin, Germany, 2 510(k) clearances
Bebig Medical GMBH is registered with the FDA (registration 3019543601) in Berlin, Germany. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 20, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019543601
- Address
- Karower Damm 9, Berlin, Germany, 13129
- Owner or operator
- BEBIG Medical GmbH (10081915)
- Roles
- Manufacturer
- First device listed
- May 26, 2021
- Registered through
- 2026
- Brand names listed
- SagiNova, SagiNova Applicators, Transfer Tubes and Accessories, SagiPlan
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | 2 | Manufacturer | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| May 20, 2015 | K141900 | SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE | MUJ | Substantially Equivalent | Eckert & Ziegler Bebig GmbH | accessdata.fda.gov |
| April 17, 2015 | K142986 | SagiNova | JAQ | Substantially Equivalent | Eckert & Ziegler Bebig GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of System, Planning, Radiation Therapy Treatment
- All makers of System, Applicator, Radionuclide, Remote-Controlled
Updated May 20, 2015. 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.