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Exactech, Inc.

Manufacturer of medical devices registered in the European database in Gainesville, United States.

Registration number (SRN)US-MF-000017730
Short nameExac
RoleManufacturer
StatusActive
CountryUnited States
City32653-1630 Gainesville
AddressNW 66th Court, 2320 32653-1630 Gainesville
Registered on2021-12-06

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entryEXACTECH, INC. (US) · FDA 1038671

Notified body certificates

CertificateStatusExpiryTypeBody
MDR 761535valid2031-06-17Technical documentationNB 2797
40480amended2031-04-15Quality management systemNB 0459
39968amended2029-08-29Quality management systemNB 0459

⚠️ State of the register on 2026-08-20. EUDAMED shows only the current version of a certificate — earlier versions are not published, by the Commission or by anyone. A certificate shown as valid here may have changed since. For a legally binding check, consult EUDAMED directly.

The SRN is the registration number assigned by the European Commission. It has been mandatory since 28 May 2026 for any operator placing a medical device on the Union market. Contact details are published in the official register; we do not reproduce them here.

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