BHM-Tech Produktionsgesellschaft m.b.H.
AT-MF-000020414 · Austria · Grafenschachen
BHM-Tech Produktionsgesellschaft m.b.H. is registered in the European database on medical devices as a manufacturer, with 186 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 186 |
|---|
Most frequent device types declared: AN-Evo1/L/BR, BC-1/GR7024, BC-2LD/GR7024, CONTACT-MINI-V/MONAURAL/SW, CONTACT-MINI/BINAURAL/BL.
Among these devices, 51 are declared active, 6 with a measuring function.
Devices declared under this manufacturer
- EXTENSION-TIP/4/GO
- EXTENSION-TIP/8/SI
- EXTENSION-TIP/8/SW
- FUNCTION-CAP-BLUE-SIZE-S
- HEADBAND-SOFT-CLOTH-39/41/BABYBLUE
- HEADBAND-SOFT-CLOTH-VELCRO-49/FIERY
- HEADBAND-SOFT-CLOTH-VELCRO-51/COFFEE
- HEADBAND-SOFT-CLOTH-VELCRO-53/JETBLACK
- Hearbow for ADHEAR
- JOSEPHINE-55/18/SI
- SOFTBAND/BC6/BIN/BG
- SPECTACLES-ADAPTER-BC6/R/BR
Showing 12 of 186 declared devices.
Catalogue references include 77733403, 77733404, 77734412, 77734820, 77735040, 77735338.
European nomenclature codes declared: Y214580, Y21450902, Y21450902,Y21450903,Y21450904, Y21450901, Z121401, Z129092.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BHM-Tech Produktionsgesellschaft mbH (AT) · FDA 3005150478 |
| Devices in EUDAMED | 186 |
| Country of registration | Austria |
Device-level evidence
| Devices with a numeric GTIN | 186 |
|---|---|
| Found in the U.S. device database | 100 |
| Share | 53.8 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. BHM-Tech Produktionsgesellschaft m.b.H. is registered in the United States but was not found in the Canadian register.