Gm Dos Reis Industria E Comercio L T D A

FDA Filings

This page includes the latest FDA filings for Gm Dos Reis Industria E Comercio L T D 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: 3013756169
• FEI Number: 3013756169
• Name: Passarini Regulatory Affairs of America, LLC
• Owner & Operator: GM dos Reis Industria e Comercio Ltda
• Contact Address: Avenida Pierre Simon de La Place, 600 ; Campinas BR-SP Sao Paulo 13069320 BR
• Official Correspondent:
  • Paula Oliveira
  • 55-19-3765-9900
• US Agent:
  • Passarini Regulatory Affairs of America, LLC
  • 866 2641043
  • usagent@rapassarini.com.br
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 201 S. Biscayne Blvd, Suite 1200 ; Miami, FL 33131 US
• Establishment Type: Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GUDID 07901125601055 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 308-912	2026-03-02
GUDID 07901125601048 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 308-907-15AO	2026-03-02
GUDID 07901125601031 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 308-905-11AO	2026-03-02
GUDID 07901125601024 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1029	2026-03-02
GUDID 07901125600706 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Minidriver Solaris 350-100	2026-03-02
GUDID 07899258696164 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1041	2026-03-02
GUDID 07899258695662 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1047	2026-03-02
GUDID 07899258695655 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1046	2026-03-02
GUDID 07899258695648 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1044	2026-03-02
GUDID 07899258695631 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1043	2026-03-02
GUDID 07899258695235 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Screw Removal Kit 353-7000	2026-03-02
GUDID 07899258695228 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Screw Removal Kit 353-6000	2026-03-02
GUDID 07899258695211 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Screw Removal Kit 353-5000	2026-03-02
GUDID 07899258695204 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Screw Removal Kit 353-4000	2026-03-02
GUDID 07899258695198 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Screw Removal Kit 353-3000	2026-03-02
GUDID 07899258695181 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Screw Removal Kit 353-2000	2026-03-02
GUDID 07899258695174 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Screw Removal Kit 353-1000	2026-03-02
GUDID 07899258694832 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1050	2026-03-02
GUDID 07899258694825 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1049	2026-03-02
GUDID 07899258694818 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1048	2026-03-02
GUDID 07899258694801 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1045	2026-03-02
GUDID 07899258694795 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1042	2026-03-02
GUDID 07899258694788 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1031	2026-03-02
GUDID 07899258694771 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1030	2026-03-02
GUDID 07899258694764 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1028	2026-03-02
GUDID 07899258694757 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1027	2026-03-02
GUDID 07899258694740 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1026	2026-03-02
GUDID 07899258694733 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1025	2026-03-02
GUDID 07899258694726 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1024	2026-03-02
GUDID 07899258694719 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1023	2026-03-02
GUDID 07899258694702 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1022	2026-03-02
GUDID 07899258660998 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1032	2026-03-02
GUDID 07899258660981 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1033	2026-03-02
GUDID 07899258660974 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1040	2026-03-02
GUDID 07899258660967 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1039	2026-03-02
GUDID 07899258660950 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1038	2026-03-02
GUDID 07899258660943 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1037	2026-03-02
GUDID 07899258660936 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1036	2026-03-02
GUDID 07899258660929 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1035	2026-03-02
GUDID 07899258660912 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1034	2026-03-02
GUDID 07899258648057 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 900-101	2026-03-02
GUDID 07899258639062 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 900-99	2026-03-02
GUDID 07899258638973 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 900-150	2026-03-02
GUDID 07899258602035 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 308-909	2026-03-02
GUDID 07899258602028 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 308-903	2026-03-02
GUDID 07901125601017 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1020	2026-02-27
GUDID 07901125601000 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1001	2026-02-27
GUDID 07901125600997 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-GV16-191	2026-02-27
GUDID 07901125600980 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-AL15-190	2026-02-27
GUDID 07901125600973 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-CB285-151	2026-02-27
GUDID 07901125600966 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-P65-165	2026-02-27
GUDID 07901125600959 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-IN35-195	2026-02-27
GUDID 07901125600942 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-IN45-195	2026-02-27
GUDID 07901125600935 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-B60-455	2026-02-27
GUDID 07901125600928 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-B40-455	2026-02-27
GUDID 07901125600911 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-P65-865	2026-02-27
GUDID 07901125600904 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-P45-88	2026-02-27
GUDID 07901125600898 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-P35-88	2026-02-27
GUDID 07901125600881 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-CB65-68	2026-02-27
GUDID 07901125600874 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-CB45-695	2026-02-27
GUDID 07901125600867 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-CB35-68	2026-02-27
GUDID 07901125600850 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-ES65-69	2026-02-27
GUDID 07901125600843 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-ES45-675	2026-02-27
GUDID 07901125600836 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-ES35-70	2026-02-27
GUDID 07901125600829 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-PE65-85	2026-02-27
GUDID 07901125600812 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-PE45-80	2026-02-27
GUDID 07901125600805 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-PE35-70	2026-02-27
GUDID 07901125600799 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-PE35-65	2026-02-27
GUDID 07901125600782 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-PE25-65	2026-02-27
GUDID 07901125600775 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-SW25-100	2026-02-27
GUDID 07901125600768 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-SW35-100	2026-02-27
GUDID 07901125600751 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-SW40-100	2026-02-27
GUDID 07901125600744 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-HX44-100	2026-02-27
GUDID 07901125600737 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-HX35-100	2026-02-27
GUDID 07901125600720 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-CB75-80	2026-02-27
GUDID 07901125600713 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-E157-65	2026-02-27
GUDID 07899258695624 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1018	2026-02-27
GUDID 07899258695617 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1004	2026-02-27
GUDID 07899258695600 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1003	2026-02-27
GUDID 07899258695594 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1002	2026-02-27
GUDID 07899258694696 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1021	2026-02-27
GUDID 07899258694689 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1019	2026-02-27
GUDID 07899258694672 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1017	2026-02-27
GUDID 07899258694665 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1016	2026-02-27
GUDID 07899258694658 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1015	2026-02-27
GUDID 07899258660752 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1005	2026-02-27
GUDID 07899258660745 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1006	2026-02-27
GUDID 07899258660738 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1007	2026-02-27
GUDID 07899258660721 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1008	2026-02-27
GUDID 07899258660714 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1009	2026-02-27
GUDID 07899258660707 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1010	2026-02-27
GUDID 07899258660691 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1011	2026-02-27
GUDID 07899258660684 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1012	2026-02-27
GUDID 07899258660677 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1013	2026-02-27
GUDID 07899258660660 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 353-109-1014	2026-02-27
GUDID 07901125600683 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 308-917	2026-02-23
GUDID 07899258602004 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 308-916	2026-02-23
GUDID 07899258601991 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 308-914	2026-02-23
GUDID 07899258601984 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 308-913	2026-02-23
GUDID 07901125600645 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 180-BD-SW1-100-FU	2026-02-12
PMN K200332 GM Dos Reis Industria E Comercio Ltda	EXPERT - Joint Fixation System	2020-10-29
PMN K182718 | HWC Passarini Regulatory Affairs of America, LLC [GM dos Reis Industria e Comercio Ltda]	Mini and Micro Fragments Reconstruction System - GMReis	2020-01-02
PMN K182718 | HRS Passarini Regulatory Affairs of America, LLC [GM dos Reis Industria e Comercio Ltda]	Mini and Micro Fragments Reconstruction System - GMReis	2020-01-02
MDM Passarini Regulatory Affairs of America, LLC [GM dos Reis Industria e Comercio Ltda]	Instrument, Manual, Surgical, General Use	2019-05-31
HWT Passarini Regulatory Affairs of America, LLC [GM dos Reis Industria e Comercio Ltda]	Template	2019-05-31
HWE Passarini Regulatory Affairs of America, LLC [GM dos Reis Industria e Comercio Ltda]	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	2019-05-31
FSM Passarini Regulatory Affairs of America, LLC [GM dos Reis Industria e Comercio Ltda]	Tray, Surgical, Instrument	2019-05-31
PMN K180626 | NKB Passarini Regulatory Affairs of America, LLC [GM dos Reis Industria e Comercio Ltda]	Pedimax II - Pedicular Screw Spinal System	2019-02-27