Data / Medical devices / Germany / SOMATEX Medical Technologies GmbH
SOMATEX Medical Technologies GmbH: FDA-registered device maker in Blankenfelde-Mahlow Brandenburg, Germany, 4 510(k) clearances
SOMATEX Medical Technologies GmbH is registered with the FDA (registration 3014090621) in Blankenfelde-Mahlow Brandenburg, Germany. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 18, 2021. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3014090621
- Address
- Blankenfelder Dorfstrasse 94, Blankenfelde-Mahlow Brandenburg, Germany, 15827
- Owner or operator
- HOLOGIC, INC. (9007676)
- Roles
- Exporter to the US
- First device listed
- March 24, 2017
- Registered through
- 2027
- Brand names listed
- TuFlex, TuFlex Premium, TuLoc, TuLoc Premium, Tumark Professional, Tumark Professional Q, Tumark Professional Q-Shape, Tumark Q and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Marker, Radiographic, Implantable | NEU | 2 | Exporter to the US | accessdata.fda.gov |
| Needle, Tumor Localization | MIJ | 1 | Exporter to the US | 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 18, 2021 | K201863 | Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape | NEU | Substantially Equivalent | Somatex Medical Technologies GmbH | accessdata.fda.gov |
| October 31, 2018 | K182082 | Tumark for Eviva, Tumark for Brevera | NEU | Substantially Equivalent | Somatex Medical Technologies GmbH | accessdata.fda.gov |
| February 17, 2010 | K093064 | TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560 | NEU | Substantially Equivalent | Somatex Medical Technologies GmbH | accessdata.fda.gov |
| March 19, 2008 | K073095 | TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560 | NEU | Substantially Equivalent | Somatex Medical Technologies GmbH | accessdata.fda.gov |
Compare with other makers
Updated February 18, 2021. 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.