EU → US Device Access

BIRR Biosciences BV

NL-MF-000023194 · Netherlands · Breukelen

BIRR Biosciences BV is registered in the European database on medical devices as a manufacturer, with 37 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa37

Most frequent device types declared: TD03, TD10, TD20.

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 entryBIRR BIOSCIENCES BV (NL) · FDA 3017140490
Devices in EUDAMED37
Country of registrationNetherlands

Notified body certificates

CertificateStatusExpiry
BE25/00000073restricted2030-03-21

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