Labsystems Diagnostics Oy
FI-MF-000018281 · Finland · Vantaa
Labsystems Diagnostics Oy is registered in the European database on medical devices as a manufacturer, with 75 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: 5550300, 6111320, 72500333, 8100411, 8100412.
Among these devices, 6 are declared sterile.
Devices declared under this manufacturer
- Biocard Chlamydia pneumoniae IgM
- Biocard™ H pylori IgG Home
- Chlamydia pneumoniae IgM EIA
- MYCOPLASMA PNEUMONIAE IgA EIA
- MYCOPLASMA PNEUMONIAE IgG EIA
- NS96 Disc Remover
- NeoMass AAAC Plus Eluent Solution
- NeoMass AAAC Plus Extraction Solution B
- NeoNat SCID Real-Time PCR Kit
- NeoNat SCID-SMA Multiplex Real-Time PCR Kit
- Neonatal Biotinidase
- Neonatal Galactose
Showing 12 of 75 declared devices.
Catalogue references include 3-018-200, 3-034-000, 6111400, 6199821, 710011009, 710011010.
European nomenclature codes declared: W0106010299, W0105040519, W02069080, W0102152202, W0101050301, W01019099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | LABSYSTEMS DIAGNOSTICS (FI) · FDA 3005342322 |
| Devices in EUDAMED | 75 |
| Country of registration | Finland |
Device-level evidence
| Devices with a numeric GTIN | 75 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | LABSYSTEMS DIAGNOSTICS OY |
North American profile: Both markets. Labsystems Diagnostics Oy is registered in both the United States and Canada.