Data / Medical devices / Germany / Biocer Entwicklungs-Gmbh
Biocer Entwicklungs-Gmbh: FDA-registered device maker in Bayreuth Bavaria, Germany, 1 510(k) clearance
Biocer Entwicklungs-Gmbh is registered with the FDA (registration 3009749957) in Bayreuth Bavaria, Germany. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 17, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009749957
- Address
- Ludwig-Thoma-Strasse 36c, Bayreuth Bavaria, Germany, 95447
- Owner or operator
- BioCer Entwicklungs-GmbH (10041544)
- Roles
- Manufacturer
- First device listed
- August 3, 2012
- Registered through
- 2026
- Brand names listed
- Ti02Mesh¿
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects | OXJ | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 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 |
|---|---|---|---|---|---|---|
| July 17, 2012 | K113311 | TIO2MESH TM | FTL | Substantially Equivalent | Biocer Entwicklungs GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Mesh, Surgical, Polymeric
- All makers of Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
Updated July 17, 2012. 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.