Roche Diabetes Care G M B H

FDA Filings

This page includes the latest FDA filings for Roche Diabetes Care G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3011806823
• FEI Number: 3011806823
• Name: Roche Diabetes Care GmbH
• Owner & Operator: Roche Diagnostics Operations Inc.
• Contact Address: 9115 Hague Road ; Indianapolis IN 46250 US
• Official Correspondent:
  • Michael Leslie
  • x-317-5214343-x
• US Agent:
  • John T Krug II
  • ROCHE DIABETES CARE INC
  • 317 5214741
  • 317 5214287
  • john.krug@roche.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Sandhofer Strasse 116 ; Mannheim Baden-Wurttemberg, 68305 DE
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device Company	Device	Date
GUDID 04015630888634 Roche Diabetes Care GmbH	Accu-Chek Ultraflex 06593984001	2023-07-25
GUDID 04015630888627 Roche Diabetes Care GmbH	Accu-Chek Ultraflex 06593976001	2023-07-25
GUDID 04015630883806 Roche Diabetes Care GmbH	Accu-Chek Combo 05458544001	2023-07-25
GUDID 04015630883691 Roche Diabetes Care GmbH	Accu-Chek Combo 05458382001	2023-07-25
GUDID 04015630882908 Roche Diabetes Care GmbH	Accu-Chek Spirit Cartridge 05206073001	2023-07-25
GUDID 04015630882755 Roche Diabetes Care GmbH	Accu-Chek Spirit Cartridge 04949935001	2023-07-25
GUDID 04015630880119 Roche Diabetes Care GmbH	Accu-Chek Combo	2023-07-25
GUDID 04015630049974 Roche Diabetes Care GmbH	Accu-Chek Ultraflex 04626648001	2023-07-25
GUDID 04015630049967 Roche Diabetes Care GmbH	Accu-Chek Ultraflex 04626621001	2023-07-25
GUDID 04015630049950 Roche Diabetes Care GmbH	Accu-Chek Ultraflex 04626613001	2023-07-25
GUDID 04015630049943 Roche Diabetes Care GmbH	Accu-Chek Ultraflex 04626605001	2023-07-25
GUDID 04015630049936 Roche Diabetes Care GmbH	Accu-Chek Ultraflex 04626591001	2023-07-25
GUDID 04015630049929 Roche Diabetes Care GmbH	Accu-Chek Ultraflex 04626583001	2023-07-25
GUDID 04015630048601 Roche Diabetes Care GmbH	Accu-Chek Link Assist 04530039001	2023-07-25
GUDID 04015630046713 Roche Diabetes Care GmbH	Accu-Chek Rapid-D 04541103001	2023-07-25
GUDID 10064562213268 Roche Diabetes Care GmbH	Accu-Chek Safe-T-Pro 03740838001	2023-02-13
GUDID 10064562213220 Roche Diabetes Care GmbH	Accu-Chek Softclix 03146707119	2023-02-13
GUDID 10064562213213 Roche Diabetes Care GmbH	Accu-Chek Softclix 03146693119	2023-02-13
GUDID 00365702293106 Roche Diabetes Care GmbH	Accu-Chek Fastclix 05353815001	2023-02-13
GUDID 00365702292109 Roche Diabetes Care GmbH	Accu-Chek Fastclix 05353807001	2023-02-13
GUDID 04015630046775 Roche Diabetes Care GmbH	Accu-Chek Rapid-D 04541162001	2022-11-18
GUDID 04015630046751 Roche Diabetes Care GmbH	Accu-Chek Rapid-D 04541146001	2022-11-18
GUDID 04015630046744 Roche Diabetes Care GmbH	Accu-Chek Rapid-D 04541138001	2022-11-18
GUDID 04015630046089 Roche Diabetes Care GmbH	Accu-Chek Rapid-D Link 04541073001	2022-11-18
GUDID 04015630046072 Roche Diabetes Care GmbH	Accu-Chek Rapid-D Link 04541065001	2022-11-18
GUDID 04015630883479 Roche Diabetes Care GmbH	Accu-Chek Combo 05391512001	2021-09-20
GUDID 04015630882700 Roche Diabetes Care GmbH	Accu-Chek Rapid-D 04925769001	2021-09-20
GUDID 04015630052431 Roche Diabetes Care GmbH	Accu-Chek Ultraflex 04847423001	2021-09-20
GUDID 04015630046782 Roche Diabetes Care GmbH	Accu-Chek Rapid-D 04541189001	2021-09-20
GUDID 04015630046768 Roche Diabetes Care GmbH	Accu-Chek Rapid-D 04541154001	2021-09-20
GUDID 04015630046706 Roche Diabetes Care GmbH	Accu-Chek Rapid-D 04541090001	2021-09-20
GUDID 04015630888658 Roche Diabetes Care GmbH	Accu-Chek Ultraflex 06594000001	2021-01-15
GUDID 04015630888610 Roche Diabetes Care GmbH	Accu-Chek Ultraflex 06593968001	2021-01-15
GUDID 04015630881505 Roche Diabetes Care GmbH	Accu-Chek Combo 07870434001	2021-01-15
GUDID 04015630046737 Roche Diabetes Care GmbH	Accu-Chek Rapid-D 04541120001	2021-01-15
GUDID 04015630046720 Roche Diabetes Care GmbH	Accu-Chek Rapid-D 04541111001	2021-01-15
GUDID 04015630046096 Roche Diabetes Care GmbH	Accu-Chek Rapid-D Link 04541081001	2019-04-29
GUDID 04015630046065 Roche Diabetes Care GmbH	Accu-Chek Rapid-D Link 04541057001	2019-04-29
GUDID 00365702468108 Roche Diabetes Care GmbH	Accu-Chek Compact Plus 05888948160	2018-07-06
GUDID 00075537927144 Roche Diabetes Care GmbH	Accu-Chek Compact Plus 05919983160	2018-07-06
GUDID 00075537598849 Roche Diabetes Care GmbH	Accu-Chek Compact Plus 05919967160	2018-07-06
GUDID 00075537546611 Roche Diabetes Care GmbH	Accu-Chek Compact Plus 05599423160	2018-07-06
GUDID 00075537474198 Roche Diabetes Care GmbH	Accu-Chek Compact Plus 05599415160	2018-07-06
PMN K122686 | FPA Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	ACCU-CHEK ULTRAFLEX INFUSION SET	2014-03-03
PMN K113614 | NBW Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Compact Plus Test Strip	2013-10-23
PMN K113614 | NBW Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Compact Plus System	2013-10-23
PMN K113614 | NBW Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Compact Plus Meter	2013-10-23
PMN K113614 | NBW Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Compact Plus MIC 6x17 Str.	2013-10-23
PMN K113614 | NBW Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Compact Plus MIC 3x17 Str.	2013-10-23
PMN K113614 | NBW Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Compact Plus MIC 3x17 Retail	2013-10-23
PMN K113614 | NBW Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Compact Plus MIC 3x17 Med Ben	2013-10-23
PMN K113614 | NBW Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Compact Plus MIC 1x17 Str.	2013-10-23
PMN K113614 | NBW Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Compact Plus Clear Control USA	2013-10-23
PMN K113614 | NBW Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	ACCU-CHEK COMPACT PLUS SAMPLE KIT 16/CS	2013-10-23
PMN K113614 | NBW Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM	2013-10-23
PMN K113614 | LFR Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Compact Plus Test Strip	2013-10-23
PMN K113614 | LFR Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Compact Plus System	2013-10-23
PMN K113614 | LFR Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Compact Plus Meter	2013-10-23
PMN K113614 | LFR Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Compact Plus MIC 6x17 Str.	2013-10-23
PMN K113614 | LFR Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Compact Plus MIC 3x17 Str.	2013-10-23
PMN K113614 | LFR Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Compact Plus MIC 3x17 Retail	2013-10-23
PMN K113614 | LFR Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Compact Plus MIC 3x17 Med Ben	2013-10-23
PMN K113614 | LFR Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Compact Plus MIC 1x17 Str.	2013-10-23
PMN K113614 | LFR Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Compact Plus Clear Control USA	2013-10-23
PMN K113614 | LFR Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	ACCU-CHEK COMPACT PLUS SAMPLE KIT 16/CS	2013-10-23
PMN K113614 | LFR Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM	2013-10-23
PMN K063146 | KZH Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Link Assist	2013-01-03
PMN K111353 | NDC Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Combo System	2012-07-27
PMN K111353 | NBW Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Combo System	2012-07-27
PMN K111353 | LZG Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Combo System	2012-07-27
PMN K972135 | FPA Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET	2012-06-27
PMN K972135 | FPA Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Tender II	2012-06-27
PMN K972135 | FPA Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Tender I	2012-06-27
PMN K003977 | FPA Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Disetronic Rapid Subcutaneous Infusion Set	2012-02-03
PMN K003977 | FPA Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Disetronic Rapid D Subcutaneous Infusion Set	2012-02-03
PMN K003977 | FPA Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Rapid-D Link Transfer	2012-02-03
PMN K003977 | FPA Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Rapid D	2012-02-03
PMN K081389 | NBW Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	ACCU-CHEK Compact Plus [GT] US	2010-02-17
PMN K081389 | NBW Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM	2010-02-17
PMN K081389 | LFR Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	ACCU-CHEK Compact Plus [GT] US	2010-02-17
PMN K081389 | LFR Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM	2010-02-17
PMN K062395 | NBW Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Smart Pix	2008-05-30
PMN K062395 | NBW Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Smart Pix device 2 (Int)	2008-05-30
PMN K062395 | NBW Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Check Smart Pix Device Reader	2008-05-30
PMN K062395 | NBW Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	ACCU-CHEK Smart Pix Device	2008-05-30
PMN K062395 | LZG Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Smart Pix	2008-05-30
PMN K062395 | LZG Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Smart Pix device 2 (Int)	2008-05-30
PMN K062395 | LZG Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Check Smart Pix Device Reader	2008-05-30
PMN K062395 | LZG Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	ACCU-CHEK Smart Pix Device	2008-05-30
PMN K062395 | JQP Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Smart Pix	2008-05-30
PMN K062395 | JQP Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Smart Pix device 2 (Int)	2008-05-30
PMN K062395 | JQP Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Check Smart Pix Device Reader	2008-05-30
PMN K062395 | JQP Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	ACCU-CHEK Smart Pix Device	2008-05-30
FMK Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	COAGUCHEK SOFTCLIX	1984-01-10
FMK Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	Accu-Chek Softclix black Bulk 100	1984-01-10
FMK Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	ACCU-CHEK SOFTCLIX	1984-01-10
FMK Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	ACCU-CHEK SOFTCLIX Plus	1984-01-10
FMK Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	ACCU-CHEK SOFTCLIX LANCETS	1984-01-10
FMK Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	ACCU-CHEK SAFE-T-PRO	1984-01-10
FMK Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	ACCU-CHEK SAFE-T-PRO PLUS	1984-01-10
FMK Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	ACCU-CHEK MULTICLIX	1984-01-10
FMK Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	ACCU-CHEK MULTICLIX LANCETS	1984-01-10
FMK Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	ACCU-CHEK FASTCLIX	1984-01-10
FMK Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]	ACCU-CHEK FASTCLIX KIT HEALTH NETWORK US	1984-01-10

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092962564	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	TOTAL 35 PALLETS = 1 PALLET ACCU-CHEK ACTIVE 25 TESTS = 5 PALLETS ACCU-CHEK SOFTCLIX LANCET (100) = 10 PALLETS	35 PKG
2020092856235	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	TOTAL 35 PALLETS = 1 PALLET ACCU-CHEK ACTIVE 25 TESTS = 5 PALLETS ACCU-CHEK SOFTCLIX LANCET (100) = 10 PALLETS	35 PKG
2018121262252	Anvers,Belgium -> Charleston, South Carolina	TOTAL 24 PALLETS = 23 PALLETS ACCU-CHEK ACTIVE KIT MG DL = 1 PALLET ACCU-CHEK ACTIVE 50 TESTS . TEMPERATURE TO BE MAIN-	24 PKG
2018121135864	Anvers,Belgium -> Charleston, South Carolina	TOTAL 42 PALLETS = 8 PALLETS ACCU-CHEK ACTIVE 50 TESTS = 23 PALLETS ACCU-CHEK SAFE-T-PRO PLUS NON-EU = 4 PALLETS	42 PKG
2018121135430	Anvers,Belgium -> Charleston, South Carolina	TOTAL 46 PALLETS = 23 PALLETS ACCU-CHEK SAFE-T-PRO PLUS NON-EU = 23 PALLETS ACCU-CHEK SAFE-T-PRO UNO .	46 PKG
2018121135732	Anvers,Belgium -> Charleston, South Carolina	46 PALLETS ACCU-CHEK ACTIVE 50 TESTS . TEMPERATURE TO BE MAIN- TAINED AT PLUS 20 DEGREES CELCIUS THE WHOLE VOYAGE .	46 PKG
2018120543512	Anvers,Belgium -> Charleston, South Carolina	TOTAL 46 PALLETS = 23 PALLETS ACCU-CHEK SAFE-T-PRO PLUS NON-EU = 23 PALLETS ACCU-CHEK SAFE-T-PRO UNO .	46 PKG
2018120543667	Anvers,Belgium -> Charleston, South Carolina	46 PALLETS ACCU-CHEK ACTIVE 50 TESTS . TEMPERATURE TO BE MAIN- TAINED AT PLUS 20 DEGREES CELCIUS THE WHOLE VOYAGE .	46 PKG