EU → US Device Access

LIMACORPORATE S.p.A.

IT-MF-000010690 · Italy · Villanova di San Daniele del Friuli

LIMACORPORATE S.p.A. is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class I7
Class IIa4

Most frequent device types declared: 80333902A040BL, REVISION HIP, 80333902A016BP, DELTA-ONE-TT CUP, DELTA SPACER.

Among these devices, 7 are declared sterile, 7 implantable, 4 reusable.

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 entryLimacorporate S.p.A. (IT) · FDA 3008395353
Devices in EUDAMED11
Country of registrationItaly

Notified body certificates

CertificateStatusExpiry
G13 075731 0072reissued2030-05-21
G12 075731 0076supplemented2027-10-16
G11 075731 0074reissued2030-05-21
G10 075731 0077restricted2027-10-23
018-00-09-MDRsupplemented2028-05-03

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