Labquality Oy
FI-MF-000019825 · Finland · Helsinki
Labquality Oy is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- B-Trol ESR Control L1
- B-Trol ESR Control L2
- B-Trol Plus Control Abnormal Level
- B-Trol Plus Control Normal Level
- CRP Control 100
- CRP Control 140
- CRP Control 15
- CRP Control 25
- CRP Control 40
- CRP Control 60
- CRP Control 60 Blue
- CRP Control POC
Showing 12 of 14 declared devices.
Catalogue references include BI0000128, BI0000129, BI0000130, BI0000131, BI0000138, BI0000420.
European nomenclature codes declared: W0102152099, W0103010501, W0103010502.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 14 |
| Country of registration | Finland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
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. Labquality Oy was not found in either the U.S. or the Canadian register.