Helago-Pharma GmbH & Co. KG
DE-MF-000004933 · Germany · Parchim
Helago-Pharma GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 66 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 52 |
|---|---|
| Class IIa | 14 |
Most frequent device types declared: Haftcreme \, Dentitex x128 DE / PL / PT / BE / FR / NL / ES, Protefix Aktivreiniger x32 PT, Senti2 x30, Labell whitening x36.
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 | 66 |
| 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.