Data / Medical devices / Austria / Safersonic Medizinprodukte Handelsges.m.b.h
Safersonic Medizinprodukte Handelsges.m.b.h: FDA-registered device maker in Persenbeug Niederosterreich, Austria, 2 510(k) clearances
Safersonic Medizinprodukte Handelsges.m.b.h is registered with the FDA (registration 3008177921) in Persenbeug Niederosterreich, Austria. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 4, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008177921
- Address
- Hauptstrasse 16/2, Persenbeug Niederosterreich, Austria, A-3680
- Owner or operator
- SAFERSONIC Medizinprodukte Handelsges.m.b.H (10057303)
- Roles
- Exporter to the US, Specification developer
- First device listed
- July 20, 2018
- Registered through
- 2027
- Brand names listed
- DAN-33505N-WG, DAN-33505NWG Safersonic Medium Narrow with Gel, DAN-33512NWG Safersonic Conti Narrow with Gel, DAN-33803 Safersonic Single, DAN-33803NT Safersonic Single - No Tape, DAN-33803U Safersonic Single Non Sterile, DAN-33803WG Safersonic Single with Gel, DAN-33805 Safersonic Medium and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Media, Coupling, Ultrasound | MUI | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Regional Anesthesia Kit | OFV | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Exporter to the US, Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 4, 2019 | K190591 | Safergel Sterile Ultrasound Gel | MUI | Substantially Equivalent | Safersonic Us, Inc. | accessdata.fda.gov |
| November 10, 2009 | K092858 | SAFERSONIC SONOGRAPHY COVER | ITX | Substantially Equivalent | Safersonic Medizinprodukte GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Regional Anesthesia Kit
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Media, Coupling, Ultrasound
Updated October 4, 2019. 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.