Labex Reagens AB
SE-MF-000048594 · Sweden · Helsingborg
Labex Reagens AB is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- Autolyse ABX
- Autolyse CD
- Autolyse CD 3500
- Autolyse KX
- Diluent ABX
- Diluent CD
- Diluent KX
- Diluent pH-7
- Diluent pH7
- Referant CD
- Referent CD
- Sheath CD
Showing 12 of 31 declared devices.
Catalogue references include DI001, DI003CT, DI007, DI061, DI071, LY070.
European nomenclature codes declared: W01030199, W01030399.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 31 |
| Country of registration | Sweden |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 31 |
|---|---|
| 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. Labex Reagens AB was not found in either the U.S. or the Canadian register.