EU → US Device Access

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

other7

Most frequent device types declared: AIA-PACK DILUENT CONCENTRATE, AIA-PACK MULTI ANALYTE CONTROL, AIA-PACK WASH CONCENTRATE, HSi Hemolysis & Wash Solution-(L), Hemolysis Stability Solution 6 x 100 ml.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
Country of registrationBelgium
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
HX 1936892-1supplemented2029-10-29

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