EU → US Device Access

BEDAL INTERNATIONAL

BE-MF-000001242 · Belgium · DIEPENBEEK

BEDAL INTERNATIONAL is registered in the European database on medical devices as a manufacturer, with 58 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa58

Most frequent device types declared: FlexGRIP.

Among these devices, 37 are declared sterile.

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 registerRegistered with FDA
Matched entryBEDAL International NV (BE) · FDA 3013415761
Devices in EUDAMED58
Country of registrationBelgium

Notified body certificates

CertificateStatusExpiry
BE24/00000301issued2029-11-27

Other manufacturers in Belgium

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