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: Dentitex x128 DE / PL / PT / BE / FR / NL / ES, Haftcreme \, Labell whitening x36, Novafix Triple Acción x66, Novafix x96.
Devices declared under this manufacturer
- Dentitex x128
- Dr. Max PRO32 x30 IT/RO/RS
- Farline pastillas limpiadoras x96
- Labell whitening x36
- Livsane
- Novafix Triple Acción x66
- Novafix x96
- Oravine 40g
- Pingo Doce Tabletas x32
- Protefix Aktivreiniger x32 Dänisch DK
- Protefix Aktivreiniger x32 Englisch GB
- Protefix Aktivreiniger x32 PT
Showing 12 of 66 declared devices.
Catalogue references include 900030, 900035, 900047, 900073, 900258, 900665.
European nomenclature codes declared: D0599, Q010280.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 66 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 66 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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: Neither register. Helago-Pharma GmbH & Co. KG was not found in either the U.S. or the Canadian register.