Elitechgroup S P A

FDA Filings

This page includes the latest FDA filings for Elitechgroup S P A. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3011461582
• FEI Number: 3011461582
• Name: ELITechGroup S.p.A.
• Owner & Operator: ELITechGroup Inc.
• Contact Address: 370 West 1700 South ; Logan UT 84321 US
• Official Correspondent:
  • Bryce McEuen
  • 1-435-7526011-1487
• US Agent:
  • Bryce McEuen
  • ELITECHGROUP INC
  • 435 7526011
  • 435 7524127
  • b.mceuen@elitechgroup.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Corso Svizzera 185 ; Torino Piemonte, 10149 IT
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 03661540900006 ELITECHGROUP SPA	ELITe InGenius® INT030-K	2020-07-07
PMN K180559 | PGI ELITechGroup S.p.A. [ELITechGroup Inc.]	Elite InGenius	2018-12-06
PMN K180559 | PGI ELITechGroup S.p.A. [ELITechGroup Inc.]	ELITe MGB HSV 1&2 Assay	2018-12-06
PMN K180559 | OOI ELITechGroup S.p.A. [ELITechGroup Inc.]	Elite InGenius	2018-12-06
PMN K180559 | OOI ELITechGroup S.p.A. [ELITechGroup Inc.]	ELITe MGB HSV 1&2 Assay	2018-12-06

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