Data / Medical devices / Germany / Compumedics Germany GmbH
Compumedics Germany GmbH: FDA-registered device maker in Singen Baden-Wurttemberg, Germany, 1 510(k) clearance
Compumedics Germany GmbH is registered with the FDA (registration 3004752776) in Singen Baden-Wurttemberg, Germany. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 5, 2005. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004752776
- Address
- Josef-Schuettler-Strasse 2, Singen Baden-Wurttemberg, Germany, 78224
- Owner or operator
- COMPUMEDICS LIMITED (9031043)
- Roles
- Manufacturer
- First device listed
- February 9, 2007
- Registered through
- 2026
- Brand names listed
- Doppler-BoxX, Doppler-BoxX1, EZ-Dop, Multi-Dop Tdigital, Multi-Dop Tdigital (+CO2), Multi-Dop Xdigital, Multi-Dop Xdigital (+CO2)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 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 5, 2005 | K051085 | DOPPLER-BOX | IYN | Substantially Equivalent | Compumedics Germany Gmgh | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
Updated May 5, 2005. 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.