Mobidiag Ltd.
FI-MF-000001215 · Finland · Espoo
Mobidiag Ltd. is registered in the European database on medical devices as a manufacturer, with 34 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- Amplidiag Bacterial GE Calibration Kit
- Amplidiag Bacterial GE Kit
- Amplidiag C. difficile+027 Kit
- Amplidiag COVID-19 Calibration Kit
- Amplidiag Easy Extraction Kit I
- Amplidiag Easy Process Control I
- Amplidiag Easy Process Control II
- Amplidiag H. pylori+ClariR Calibration Kit
- Amplidiag Viral GE Calibration Kit
- Amplidiag Viral GE Kit
- Novodiag COVID-19
- Novodiag RESP-4
Showing 12 of 34 declared devices.
Catalogue references include AD-CVCS-30, AD-VGE-100, AD-VGECS-30, AE-RC802x8, AE-RC803x8, MD-NATS-50.
European nomenclature codes declared: W01040699, W0105070503, W05019099, W0105070504, W0104080607, W02050116.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 34 |
| 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 | 34 |
|---|---|
| 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. Mobidiag Ltd. was not found in either the U.S. or the Canadian register.