Data / Medical devices / Austria / BHM-Tech Produktionsgesellschaft mbH
BHM-Tech Produktionsgesellschaft mbH: FDA-registered device maker in Grafenschachen Burgenland, Austria, 2 510(k) clearances
BHM-Tech Produktionsgesellschaft mbH is registered with the FDA (registration 3005150478) in Grafenschachen Burgenland, Austria. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated April 25, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005150478
- Address
- Grafenschachen 242, Grafenschachen Burgenland, Austria, 7423
- Owner or operator
- BHM-Tech Produktionsgesellschaft mbH (10044610)
- Roles
- Manufacturer
- First device listed
- May 25, 2016
- Registered through
- 2026
- Brand names listed
- AN-Evo1, Apollon, BHMFit contact forte, BHMFit contact mini, BHMFit contact star evo1, BHMFit2, Hearbow, contact and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hearing Aid, Bone Conduction | LXB | 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 |
|---|---|---|---|---|---|---|
| April 25, 2025 | K243041 | contact forte Alpha | LXB | Substantially Equivalent | Bhm-Tech Produktionsgesellschaft Mbh | accessdata.fda.gov |
| November 1, 2012 | K121793 | AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON | LXB | Substantially Equivalent | Audifon-USA, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 25, 2025. 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.