Tosoh Europe N.V.
BE-MF-000000210 · Belgium · Tessenderlo-Ham
Tosoh Europe N.V. is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: AIA-PACK DILUENT CONCENTRATE, AIA-PACK MULTI ANALYTE CONTROL, AIA-PACK WASH CONCENTRATE, HSi Hemolysis & Wash Solution-(L), HSi Hemolysis & Wash Solution-(LL).
Devices declared under this manufacturer
- AIA-PACK DILUENT CONCENTRATE
- AIA-PACK MULTI ANALYTE CONTROL
- AIA-PACK WASH CONCENTRATE
- HSi Hemolysis & Wash Solution-(L)
- HSi Hemolysis & Wash Solution-(LL)
- Hemolysis Collection System 10 µL
- Hemolysis Stability Solution 6 x 100 ml
Catalogue references include 0020955, 0020956, 018431L, 019550L, 0960474, 0968700.
European nomenclature codes declared: W0201020185, W01010214, W0103010202, W01021521.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 7 |
| Country of registration | Belgium |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 7 |
|---|---|
| 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. Tosoh Europe N.V. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HX 1936892-1 | supplemented | 2029-10-29 |