Biohit Oyj
FI-MF-000014642 · Finland · Helsinki
Biohit Oyj is registered in the European database on medical devices as a manufacturer, with 43 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 2 |
|---|
Most frequent device types declared: HIT-92A.
Devices declared under this manufacturer
- Acetium 100 mg
- BIOHIT FAEX Sample System
- BIOHIT Lactase Control
- BIOHIT 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 UFT300
- GP Reader NT
- Gastrin-17 Advanced
- GastroPanel® Gastrin-17
- GastroPanel® quick test
- GastroPanel® 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪
- GastroSoft
- Lactose Intolerance quick test
- Pepsinogen II
Showing 12 of 43 declared devices.
Catalogue references include 602019, 602320, 602600, 606035, 606040, 620000C.
European nomenclature codes declared: W01021499, W0105090102, W0201069099, W01021699, W05019001, W0102019099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BIOHIT OYJ (FI) · FDA 9681721 |
| Devices in EUDAMED | 43 |
| Country of registration | Finland |
Device-level evidence
| Devices with a numeric GTIN | 41 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 2.4 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BIOHIT OYJ |
North American profile: Both markets. Biohit Oyj is registered in both the United States and Canada.