Berner Oy
FI-MF-000007402 · Finland · Helsinki
Berner Oy is registered in the European database on medical devices as a manufacturer, with 126 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 126 |
|---|
Most frequent device types declared: Class I Health Care, Glove, Vinyl Gloves.
Among these devices, 2 are declared active.
Devices declared under this manufacturer
- Bea Pro Nitrile Gloves XS
- Pikobutton 30 250g GREEN
- Pikobutton 30 250g ORANGE
- Pikobutton 30 BLUE
- Pikobutton 30 GOLD
- Pikobutton 30 WATER RESISTANT BLACK
- Pikobutton 30 WATER RESISTANT GREEN
- Pikobutton 50 250g BLACK
- Pikobutton 50 250g BLUE
- Pikobutton 50 250g GOLD
- Pikobutton 50 RED
- Pikobutton 50 WHITE
Showing 12 of 126 declared devices.
Catalogue references include PB30-BLUE, PB30J-GREEN, PB30J-ORANGE, PB30WR-BLACK, PB30WR-GREEN, PB50-RED.
European nomenclature codes declared: Y2199, D0701, T0199, Q010599, V0799, M9002.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 126 |
| Country of registration | Finland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 126 |
|---|---|
| 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. Berner Oy was not found in either the U.S. or the Canadian register.