Reagena Oy
FI-MF-000002804 · Finland · Toivala
Reagena Oy is registered in the European database on medical devices as a manufacturer, with 50 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: 100072, 100211, 102256, 102256SC, 102256SCWS.
Devices declared under this manufacturer
- Eosin solution
- Formalin 10 % (1 L), phosphate buffered pH 7,2 incl. 4 % formaldehyde
- Formalin 10 % (200 L), phosphate buffered pH 7,2 incl. 4 % formaldehyd
- Formalin 10 % in sample container (380 x 10 ml), phosphate buffered pH
- Formalin 10 % in sample container with spoon (94 x 8 ml), phosphate bu
- GEWF solution
- May-Grünwald solution
- PEG-ethanol cytology fixative (120 x 25 ml)
- ReaScan CXCL13
- ReaScan TBE IgM
- ReaScan+ LYME IgM/IgG Combo
- ReaScan+ PUUMALA IgM
Showing 12 of 50 declared devices.
Catalogue references include 102256T, 115103, 125028A, 180072, 180211, 182256.
European nomenclature codes declared: W01030705, W0105099099, W0103010301, W0105040614, W0103010302, W0105090199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 50 |
| 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 | 38 |
|---|---|
| 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. Reagena Oy was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CR-04-1235-886-25 | issued | 2030-09-22 |