EU → US Device Access

Cypress Diagnostics

BE-MF-000000033 · Belgium · Hulshout

Cypress Diagnostics is registered in the European database on medical devices as a manufacturer, with 139 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

other139

Most frequent device types declared: HS001 - HS014 - HS021 - HS022, CY005/8-WS-I - II - III- IV, Urine-10 - Urine-2GK - Urine-2GP - Urine-3, CY003, HS006 - HS007 - HS009.

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 EUDAMED139
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.

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