Roche Diabetes Care GmbH

Address:Sandhofer Strasse 116,Mannheim Baden-Wurttemberg,DE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Pump, Infusion, Insulin (LZG) (4) Set, Administration, Intravascular (FPA) (4)

Premarket Exempt

Clear

Accu-Chek Spirit Cartridge - 04015630882908 Catalog Number : 05206073001

Device Description : Accu-Chek Spirit 3.15ml Cart. Sys. 25pc

Device Class :

Duns Number: 313212471

Premarket Exempt : No

Product Code : LZG

Prescription Use : No

Device Count : 25

Accu-Chek Combo - 04015630883479 Catalog Number : 05391512001

Device Description : Accu-Chek Spirit Combo Repl. US/en

Device Class : 2

Duns Number: 313212471

Premarket Exempt : No

Product Code : LZG

Prescription Use : Yes

Device Count : 1

Accu-Chek Combo - 04015630883691 Catalog Number : 05458382001

Device Description : Accu-Chek Aviva Combo Repl. mg (670)

Device Class : 2

Duns Number: 313212471

Premarket Exempt : No

Product Code : LZG

Prescription Use : Yes

Device Count : 1

Accu-Chek Combo - 04015630883806 Catalog Number : 05458544001

Device Description : Accu-Chek Combo Kit mg US/en

Device Class : 2

Duns Number: 313212471

Premarket Exempt : No

Product Code : LZG

Prescription Use : Yes

Device Count : 1

Accu-Chek Ultraflex - 04015630888610 Catalog Number : 06593968001

Device Description : Accu-Chek Ultraflex I 6/30 10pcs

Device Class :

Duns Number: 313212471

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 10

Accu-Chek Ultraflex - 04015630888627 Catalog Number : 06593976001

Device Description : Accu-Chek Ultraflex I 6/60 10pcs

Device Class :

Duns Number: 313212471

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 10

Accu-Chek Ultraflex - 04015630888634 Catalog Number : 06593984001

Device Description : Accu-Chek Ultraflex I 6/80 10pcs

Device Class :

Duns Number: 313212471

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 10

Accu-Chek Ultraflex - 04015630888658 Catalog Number : 06594000001

Device Description : Accu-Chek Ultraflex pack of two 6/60 2pc

Device Class :

Duns Number: 313212471

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 2

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