EU → US Device Access

The Surgical Company International B.V.

NL-MF-000001973 · Netherlands · Almelo

The Surgical Company International B.V. 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 IIa56
Class IIb2

Most frequent device types declared: MA0510, 671200, 670800-B, MA2280, 680911.

Among these devices, 19 are declared sterile, 5 active.

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 entryThe Surgical Company International B.V. (NL) · FDA 3038241934
Devices in EUDAMED58
Country of registrationNetherlands

Notified body certificates

CertificateStatusExpiry
2259019CE03amended2027-06-10
2259019CE02amended2027-06-10
2259019CE01supplemented2027-06-10

Other manufacturers in Netherlands

All Netherlands manufacturers →