Data / Medical devices / Germany / Eckert & Ziegler Bebig GMBH
Eckert & Ziegler Bebig GMBH: FDA-registered device maker in Berlin, Germany, 1 510(k) clearance
Eckert & Ziegler Bebig GMBH is registered with the FDA (registration 9617477) in Berlin, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 16, 1994. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 9617477
- FEI number
- 1000310011
- Address
- Robert-Rossle STR.10, Berlin, Germany, 13125
- Owner or operator
- ECKERT & ZIEGLER BEBIG GmbH (9034266)
- Roles
- Manufacturer
- First device listed
- February 10, 2011
- Registered through
- 2027
- Brand names listed
- Ru-106 Eye Applicators
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Source, Brachytherapy, Radionuclide | KXK | 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 |
|---|---|---|---|---|---|---|
| March 16, 1994 | K931393 | BEBIG PLAQUES RUM101-RUM114 | KXK | Substantially Equivalent | Bebig, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 17, 2023 | 93399 | Class II | Ongoing | SagiPlan 2.2, CE0344, Rx Only, Brachyterapy Treatment Planning System | Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements. | accessdata.fda.gov |
Compare with other makers
Updated December 8, 2023. 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.