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

Set, Administration, Intravascular (FPA) (7) Pump, Infusion, Insulin (LZG) (3)

Premarket Exempt

Clear

Accu-Chek Ultraflex - 04015630049936 Catalog Number : 04626591001

Device Description : Accu-Chek Ultraflex I 8/80 10pcs

Device Class :

Duns Number: 313212471

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 10

Accu-Chek Ultraflex - 04015630049943 Catalog Number : 04626605001

Device Description : Accu-Chek Ultraflex I 8/110 10pcs

Device Class :

Duns Number: 313212471

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 10

Accu-Chek Ultraflex - 04015630049950 Catalog Number : 04626613001

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

Device Class :

Duns Number: 313212471

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 10

Accu-Chek Ultraflex - 04015630049967 Catalog Number : 04626621001

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

Device Class :

Duns Number: 313212471

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 10

Accu-Chek Ultraflex - 04015630049974 Catalog Number : 04626648001

Device Description : Accu-Chek Ultraflex I 10/110 10pcs

Device Class :

Duns Number: 313212471

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 10

Accu-Chek Ultraflex - 04015630052431 Catalog Number : 04847423001

Device Description : Accu-Chek Ultraflex pack of two 2pcs

Device Class :

Duns Number: 313212471

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 2

Accu-Chek Combo - 04015630880119 Catalog Number :

Device Description : Accu-Chek Spirit Combo

Device Class : 2

Duns Number: 313212471

Premarket Exempt : No

Product Code : LZG

Prescription Use : Yes

Device Count : 1

Accu-Chek Combo - 04015630881505 Catalog Number : 07870434001

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

Device Class : 2

Duns Number: 313212471

Premarket Exempt : No

Product Code : LZG

Prescription Use : Yes

Device Count : 1

Accu-Chek Rapid-D - 04015630882700 Catalog Number : 04925769001

Device Description : Accu-Chek Rapid-D pack of two 2pcs

Device Class :

Duns Number: 313212471

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 2

Accu-Chek Spirit Cartridge - 04015630882755 Catalog Number : 04949935001

Device Description : Accu-Chek Spirit 3.15ml Cart. Sys. 5pcs

Device Class :

Duns Number: 313212471

Premarket Exempt : No

Product Code : LZG

Prescription Use : No

Device Count : 5

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