Happersberger otopront GmbH
DE-MF-000017407 · Germany · Hohenstein
Happersberger otopront GmbH is registered in the European database on medical devices as a manufacturer, with 70 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 70 |
|---|
Most frequent device types declared: Aures Center, BASIC PLUS, DIGITAL 5, OTOLUX-LED, PES Eco HD Package.
Among these devices, 38 are declared active, 15 with a measuring function.
Devices declared under this manufacturer
- BASIC PLUS
- DIGITAL 5
- Headlight otopront
- LED Headlight otopront
- Light Transmission Cord otopront
- PES Eco HD Package
- RHINO-SYS
- Rigid Endoscope otopront 0°
- Rigid Endoscope otopront 30°
- Rigid Endoscope otopront 70°
- Rigid Endoscope otopront 90°
- SMART
Showing 12 of 70 declared devices.
Catalogue references include 325047, 325175, 325183, 325191, 325291, 325427.
European nomenclature codes declared: Z12021099, Q030499, V08020101, Z12029080, Z12149009, Z12020401.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | HAPPERSBERGER OTOPRONT GMBH (DE) · FDA 3002807209 |
| Devices in EUDAMED | 70 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 70 |
|---|---|
| Found in the U.S. device database | 13 |
| Share | 18.6 % |
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. Happersberger otopront GmbH is registered in the United States but was not found in the Canadian register.