bitop medical GmbH
DE-MF-000047028 · Germany · Dortmund
bitop medical GmbH is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 10 |
|---|---|
| Class IIb | 7 |
Most frequent device types declared: ANS02/ANS03/ANS07, SNS01, ERS03/ERS04, EIC01, EHT01 / EHT04.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 17 |
| Country of registration | Germany |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.