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 07899258697109 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-29155-SFPK-HIP	2025-12-18
GUDID 07899258662763 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-7010-FT	2025-12-18
GUDID 07899258657424 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-55191-PE2	2025-12-18
GUDID 07899258657417 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-475191-PE3	2025-12-18
GUDID 07899258657103 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-30080-FT	2025-12-18
GUDID 07899258657097 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-25080-FT	2025-12-18
GUDID 07899258657042 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-80230-FT	2025-12-18
GUDID 07899258657035 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-70230-FT	2025-12-18
GUDID 07899258656786 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-47515-FT	2025-12-18
GUDID 07899258656670 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-5515-FT	2025-12-18
GUDID 07899258656663 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-62515-FT	2025-12-18
GUDID 07899258656632 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-4010-FT	2025-12-18
GUDID 07899258654775 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-25080	2025-12-18
GUDID 07899258654508 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-29155	2025-12-18
GUDID 07899258652979 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-55191-PE4	2025-12-18
GUDID 07899258652962 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-55191-PE3	2025-12-18
GUDID 07899258650692 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-475191-PE5	2025-12-18
GUDID 07899258650685 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-475191-PE4	2025-12-18
GUDID 07899258650678 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-351580-PE2	2025-12-18
GUDID 07899258650661 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-351580-PE1	2025-12-18
GUDID 07899258601830 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-40010-FT	2025-12-18
GUDID 07899258601816 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-29125	2025-12-18
GUDID 07899258662466 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-35485-SA	2025-12-17
GUDID 07899258662381 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-25070-SA	2025-12-17
GUDID 07899258662374 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-351580-PE3	2025-12-17
GUDID 07899258652269 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-35085-SA	2025-12-17
GUDID 07899258601823 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Suture Anchors 320-35485-PB-SA	2025-12-17
GUDID 07899258699875 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 343-80-CRAD-ES	2025-12-15
GUDID 07899258699868 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 308-720	2025-12-15
GUDID 07899258601977 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 343-80-CRAD-ES-FU	2025-12-15
GUDID 07899258601960 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 308-537AO	2025-12-15
GUDID 07899258695150 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-12US	2025-12-08
GUDID 07899258695143 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-11US	2025-12-08
GUDID 07899258695136 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-10US	2025-12-08
GUDID 07899258695129 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-09US	2025-12-08
GUDID 07899258695112 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-08US	2025-12-08
GUDID 07899258695105 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-07US	2025-12-08
GUDID 07899258695099 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-06US	2025-12-08
GUDID 07899258695082 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-05US	2025-12-08
GUDID 07899258695075 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-04US	2025-12-08
GUDID 07899258695068 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-03US	2025-12-08
GUDID 07899258695051 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-02US	2025-12-08
GUDID 07899258695037 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-35-65	2025-12-08
GUDID 07899258695020 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-35-60	2025-12-08
GUDID 07899258695013 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-35-55	2025-12-08
GUDID 07899258695006 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-35-50	2025-12-08
GUDID 07899258694993 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-35-45	2025-12-08
GUDID 07899258694986 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-35-40	2025-12-08
GUDID 07899258694979 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-35-35	2025-12-08
GUDID 07899258694962 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-35-30	2025-12-08
GUDID 07899258694955 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-35-25	2025-12-08
GUDID 07899258694948 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-35-22	2025-12-08
GUDID 07899258694931 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-35-20	2025-12-08
GUDID 07899258694924 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-35-18	2025-12-08
GUDID 07899258694917 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-35-16	2025-12-08
GUDID 07899258694900 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-35-14	2025-12-08
GUDID 07899258694894 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-35-12	2025-12-08
GUDID 07899258694887 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-35-10	2025-12-08
GUDID 07899258694870 GM DOS REIS INDUSTRIA E COMERCIO LTDA	GMReis Fibula Nail System 302-35-08	2025-12-08
GUDID 07899258699967 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Orthopedic Instruments 310-01-08AO	2025-12-03
GUDID 07899258697420 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697413 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697406 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697390 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697383 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Upper Limb Plating System	2025-10-01
GUDID 07899258697376 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697369 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697352 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697345 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697338 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697321 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697307 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697291 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697284 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697277 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697260 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Upper Limb Plating System	2025-10-01
GUDID 07899258697253 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Upper Limb Plating System	2025-10-01
GUDID 07899258697246 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Upper Limb Plating System	2025-10-01
GUDID 07899258697239 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Upper Limb Plating System	2025-10-01
GUDID 07899258697222 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Upper Limb Plating System	2025-10-01
GUDID 07899258697215 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697208 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697192 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697185 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697178 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697161 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697154 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697147 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697130 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-10-01
GUDID 07899258697314 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-09-30
GUDID 07899258697123 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Versalock Mini and Micro Plating System	2025-09-30
GUDID 07899258697024 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Stitch Cerclage - Suture Tapes	2025-09-02
GUDID 07899258697017 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Stitch Cerclage - Suture Tapes	2025-09-02
GUDID 07899258697000 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Stitch Cerclage - Suture Tapes	2025-09-02
GUDID 07899258696997 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Stitch Cerclage - Suture Tapes	2025-09-02
GUDID 07899258696980 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Stitch Cerclage - Suture Tapes	2025-09-02
GUDID 07899258696973 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Stitch Cerclage - Suture Tapes	2025-09-02
GUDID 07899258696966 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Stitch Cerclage - Suture Tapes	2025-09-02
GUDID 07899258696959 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Stitch Cerclage - Suture Tapes	2025-09-02
GUDID 07899258696942 GM DOS REIS INDUSTRIA E COMERCIO LTDA	Stitch Cerclage - Suture Tapes	2025-09-02
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