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

Glucose Dehydrogenase, Glucose (LFR) (5) Set, Administration, Intravascular (FPA) (5)

Premarket Exempt

Clear

Accu-Chek Compact Plus - 00075537474198 Catalog Number : 05599415160

Device Description : ACCU-CHEK COMPACT PLUS 51 CT RTL STR 48

Device Class :

Duns Number: 313212471

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 3

Accu-Chek Compact Plus - 00075537546611 Catalog Number : 05599423160

Device Description : Accu-Chek Compact Plus MIC 1x17 Str

Device Class : 2

Duns Number: 313212471

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

Accu-Chek Compact Plus - 00075537598849 Catalog Number : 05919967160

Device Description : ACCU-CHEK COMPACT PLUS 102CT RTL STR 24

Device Class :

Duns Number: 313212471

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 6

Accu-Chek Compact Plus - 00075537927144 Catalog Number : 05919983160

Device Description : ACCU-CHEK COMPACT PLUS 51 CT MO STRP 48

Device Class :

Duns Number: 313212471

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 3

Accu-Chek Compact Plus - 00365702468108 Catalog Number : 05888948160

Device Description : Accu-Chek Compact Plus Clear Control USA

Device Class :

Duns Number: 313212471

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

Accu-Chek Rapid-D Link - 04015630046065 Catalog Number : 04541057001

Device Description : Accu-Chek Rapid-D Link Tra. Set 20 10pcs

Device Class :

Duns Number: 313212471

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 10

Accu-Chek Rapid-D Link - 04015630046072 Catalog Number : 04541065001

Device Description : Accu-Chek Rapid-D Link Tra. Set 50 10pcs

Device Class :

Duns Number: 313212471

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 10

Accu-Chek Rapid-D Link - 04015630046089 Catalog Number : 04541073001

Device Description : Accu-Chek Rapid-D Link Tra. Set 70 10pcs

Device Class :

Duns Number: 313212471

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 10

Accu-Chek Rapid-D Link - 04015630046096 Catalog Number : 04541081001

Device Description : Accu-Chek Rapid-D Link Tra. Set 100 10pc

Device Class :

Duns Number: 313212471

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 10

Accu-Chek Rapid-D - 04015630046706 Catalog Number : 04541090001

Device Description : Accu-Chek Rapid-D 6/60 15+5+5pcs

Device Class : 2

Duns Number: 313212471

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

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