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 Number3011806823
FEI Number3011806823
NameRoche Diabetes Care GmbH
Owner & OperatorRoche Diagnostics Operations Inc.
Contact Address9115 Hague Road
Indianapolis IN 46250 US
Official Correspondent
  • Michael Leslie
  • x-317-5214343-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressSandhofer 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
DeviceDate
Roche Diabetes Care GmbH
Accu-Chek Care 100959460012024-11-15
Roche Diabetes Care GmbH
Accu-Chek Ultraflex 065939840012023-07-25
Roche Diabetes Care GmbH
Accu-Chek Ultraflex 065939760012023-07-25
Roche Diabetes Care GmbH
Accu-Chek Combo 054585440012023-07-25
Roche Diabetes Care GmbH
Accu-Chek Combo 054583820012023-07-25
Roche Diabetes Care GmbH
Accu-Chek Spirit Cartridge 052060730012023-07-25
Roche Diabetes Care GmbH
Accu-Chek Spirit Cartridge 049499350012023-07-25
Roche Diabetes Care GmbH
Accu-Chek Combo 2023-07-25
Roche Diabetes Care GmbH
Accu-Chek Ultraflex 046266480012023-07-25
Roche Diabetes Care GmbH
Accu-Chek Ultraflex 046266210012023-07-25
Roche Diabetes Care GmbH
Accu-Chek Ultraflex 046266130012023-07-25
Roche Diabetes Care GmbH
Accu-Chek Ultraflex 046266050012023-07-25
Roche Diabetes Care GmbH
Accu-Chek Ultraflex 046265910012023-07-25
Roche Diabetes Care GmbH
Accu-Chek Ultraflex 046265830012023-07-25
Roche Diabetes Care GmbH
Accu-Chek Link Assist 045300390012023-07-25
Roche Diabetes Care GmbH
Accu-Chek Rapid-D 045411030012023-07-25
Roche Diabetes Care GmbH
Accu-Chek Safe-T-Pro 037408380012023-02-13
Roche Diabetes Care GmbH
Accu-Chek Softclix 031467071192023-02-13
Roche Diabetes Care GmbH
Accu-Chek Softclix 031466931192023-02-13
Roche Diabetes Care GmbH
Accu-Chek Fastclix 053538150012023-02-13
Roche Diabetes Care GmbH
Accu-Chek Fastclix 053538070012023-02-13
Roche Diabetes Care GmbH
Accu-Chek Rapid-D 045411620012022-11-18
Roche Diabetes Care GmbH
Accu-Chek Rapid-D 045411460012022-11-18
Roche Diabetes Care GmbH
Accu-Chek Rapid-D 045411380012022-11-18
Roche Diabetes Care GmbH
Accu-Chek Rapid-D Link 045410730012022-11-18
Roche Diabetes Care GmbH
Accu-Chek Rapid-D Link 045410650012022-11-18
Roche Diabetes Care GmbH
Accu-Chek Combo 053915120012021-09-20
Roche Diabetes Care GmbH
Accu-Chek Rapid-D 049257690012021-09-20
Roche Diabetes Care GmbH
Accu-Chek Ultraflex 048474230012021-09-20
Roche Diabetes Care GmbH
Accu-Chek Rapid-D 045411890012021-09-20
Roche Diabetes Care GmbH
Accu-Chek Rapid-D 045411540012021-09-20
Roche Diabetes Care GmbH
Accu-Chek Rapid-D 045410900012021-09-20
Roche Diabetes Care GmbH
Accu-Chek Ultraflex 065940000012021-01-15
Roche Diabetes Care GmbH
Accu-Chek Ultraflex 065939680012021-01-15
Roche Diabetes Care GmbH
Accu-Chek Combo 078704340012021-01-15
Roche Diabetes Care GmbH
Accu-Chek Rapid-D 045411200012021-01-15
Roche Diabetes Care GmbH
Accu-Chek Rapid-D 045411110012021-01-15
Roche Diabetes Care GmbH
Accu-Chek Rapid-D Link 045410810012019-04-29
Roche Diabetes Care GmbH
Accu-Chek Rapid-D Link 045410570012019-04-29
Roche Diabetes Care GmbH
Accu-Chek Compact Plus 058889481602018-07-06
Roche Diabetes Care GmbH
Accu-Chek Compact Plus 059199831602018-07-06
Roche Diabetes Care GmbH
Accu-Chek Compact Plus 059199671602018-07-06
Roche Diabetes Care GmbH
Accu-Chek Compact Plus 055994231602018-07-06
Roche Diabetes Care GmbH
Accu-Chek Compact Plus 055994151602018-07-06
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
ACCU-CHEK ULTRAFLEX INFUSION SET2014-03-03
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Compact Plus Test Strip2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Compact Plus System2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Compact Plus Meter2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Compact Plus MIC 6x17 Str.2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Compact Plus MIC 3x17 Str.2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Compact Plus MIC 3x17 Retail2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Compact Plus MIC 3x17 Med Ben2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Compact Plus MIC 1x17 Str.2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Compact Plus Clear Control USA2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
ACCU-CHEK COMPACT PLUS SAMPLE KIT 16/CS2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Compact Plus Test Strip2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Compact Plus System2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Compact Plus Meter2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Compact Plus MIC 6x17 Str.2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Compact Plus MIC 3x17 Str.2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Compact Plus MIC 3x17 Retail2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Compact Plus MIC 3x17 Med Ben2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Compact Plus MIC 1x17 Str.2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Compact Plus Clear Control USA2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
ACCU-CHEK COMPACT PLUS SAMPLE KIT 16/CS2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM2013-10-23
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Link Assist2013-01-03
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Combo System2012-07-27
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Combo System2012-07-27
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Combo System2012-07-27
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET2012-06-27
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Tender II2012-06-27
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Tender I2012-06-27
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Disetronic Rapid Subcutaneous Infusion Set2012-02-03
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Disetronic Rapid D Subcutaneous Infusion Set2012-02-03
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Rapid-D Link Transfer2012-02-03
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Rapid D2012-02-03
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
ACCU-CHEK Compact Plus [GT] US2010-02-17
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM2010-02-17
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
ACCU-CHEK Compact Plus [GT] US2010-02-17
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM2010-02-17
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Smart Pix2008-05-30
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Smart Pix device 2 (Int)2008-05-30
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Check Smart Pix Device Reader2008-05-30
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
ACCU-CHEK Smart Pix Device2008-05-30
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Smart Pix2008-05-30
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Smart Pix device 2 (Int)2008-05-30
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Check Smart Pix Device Reader2008-05-30
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
ACCU-CHEK Smart Pix Device2008-05-30
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Smart Pix2008-05-30
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Smart Pix device 2 (Int)2008-05-30
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Check Smart Pix Device Reader2008-05-30
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
ACCU-CHEK Smart Pix Device2008-05-30
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
COAGUCHEK SOFTCLIX1984-01-10
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
Accu-Chek Softclix black Bulk 1001984-01-10
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
ACCU-CHEK SOFTCLIX1984-01-10
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
ACCU-CHEK SOFTCLIX Plus1984-01-10
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
ACCU-CHEK SOFTCLIX LANCETS1984-01-10
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
ACCU-CHEK SAFE-T-PRO1984-01-10
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
ACCU-CHEK SAFE-T-PRO PLUS1984-01-10
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
ACCU-CHEK MULTICLIX1984-01-10
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
ACCU-CHEK MULTICLIX LANCETS1984-01-10
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
ACCU-CHEK FASTCLIX1984-01-10
Roche Diabetes Care GmbH [Roche Diagnostics Operations Inc.]
ACCU-CHEK FASTCLIX KIT HEALTH NETWORK US1984-01-10

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092962564Anvers,Belgium -> New York/Newark Area, Newark, New JerseyTOTAL 35 PALLETS = 1 PALLET ACCU-CHEK ACTIVE 25 TESTS = 5 PALLETS ACCU-CHEK SOFTCLIX LANCET (100) = 10 PALLETS35 PKG
2020092856235Anvers,Belgium -> New York/Newark Area, Newark, New JerseyTOTAL 35 PALLETS = 1 PALLET ACCU-CHEK ACTIVE 25 TESTS = 5 PALLETS ACCU-CHEK SOFTCLIX LANCET (100) = 10 PALLETS35 PKG
2018121262252Anvers,Belgium -> Charleston, South CarolinaTOTAL 24 PALLETS = 23 PALLETS ACCU-CHEK ACTIVE KIT MG DL = 1 PALLET ACCU-CHEK ACTIVE 50 TESTS . TEMPERATURE TO BE MAIN-24 PKG
2018121135864Anvers,Belgium -> Charleston, South CarolinaTOTAL 42 PALLETS = 8 PALLETS ACCU-CHEK ACTIVE 50 TESTS = 23 PALLETS ACCU-CHEK SAFE-T-PRO PLUS NON-EU = 4 PALLETS42 PKG
2018121135430Anvers,Belgium -> Charleston, South CarolinaTOTAL 46 PALLETS = 23 PALLETS ACCU-CHEK SAFE-T-PRO PLUS NON-EU = 23 PALLETS ACCU-CHEK SAFE-T-PRO UNO .46 PKG
2018121135732Anvers,Belgium -> Charleston, South Carolina46 PALLETS ACCU-CHEK ACTIVE 50 TESTS . TEMPERATURE TO BE MAIN- TAINED AT PLUS 20 DEGREES CELCIUS THE WHOLE VOYAGE .46 PKG
2018120543512Anvers,Belgium -> Charleston, South CarolinaTOTAL 46 PALLETS = 23 PALLETS ACCU-CHEK SAFE-T-PRO PLUS NON-EU = 23 PALLETS ACCU-CHEK SAFE-T-PRO UNO .46 PKG
2018120543667Anvers,Belgium -> Charleston, South Carolina46 PALLETS ACCU-CHEK ACTIVE 50 TESTS . TEMPERATURE TO BE MAIN- TAINED AT PLUS 20 DEGREES CELCIUS THE WHOLE VOYAGE .46 PKG

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