LifeScan Europe GmbH

Address:Gubelstrasse 34,CH Zug,CH

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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

System, Test, Blood Glucose, Over The Counter (NBW) (8) Glucose Dehydrogenase, Glucose (LFR) (5) Lancet, Blood (FMK) (2)

Premarket Exempt

No Yes

Clear

OneTouch Ultrasoft - 00353885012447 Catalog Number :

Device Description : OneTouch Ultrasoft Lancets

Device Class :

Duns Number: 480240820

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 10

OneTouch Verio Reflect - 00353885012478 Catalog Number :

Device Description : OneTouch Verio Reflect Blood Glucose Monitoring System. Starter Kit.

Device Class : 2

Duns Number: 480240820

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

OneTouch Verio Flex - 00353885012485 Catalog Number :

Device Description : OneTouch Verio Flex Blood Glucose Monitoring System

Device Class : 2

Duns Number: 480240820

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 1

OneTouch Verio - 00353885012591 Catalog Number :

Device Description : OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. For in vitro diagnostic use. For self-testing

Device Class :

Duns Number: 480240820

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 25

OneTouch Verio - 00353885012614 Catalog Number :

Device Description : OneTouch Verio Test Strips. For Blood Glucose testing with OneTouch Verio Family OneTouch Verio Test Strips. For Blood Glucose testing with OneTouch Verio Family of meters. For in vitro diagnostic use. For self testing.

Device Class :

Duns Number: 480240820

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 60

OneTouch Ultra Plus Flex - 00353885012621 Catalog Number :

Device Description : OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System

Device Class : 2

Duns Number: 480240820

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 1

OneTouch Ultra Plus - 00353885012638 Catalog Number :

Device Description : OneTouch Ultra® Plus strips work with OneTouch Ultra Plus Flex(TM) meter.

Device Class :

Duns Number: 480240820

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 30

OneTouch Ultra Plus - 00353885012645 Catalog Number :

Device Description : OneTouch Ultra Plus™ Level 3 Control Solution for Use with OneTouch Ultra Plus F OneTouch Ultra Plus™ Level 3 Control Solution for Use with OneTouch Ultra Plus Flex™ Meter.

Device Class :

Duns Number: 480240820

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 75

OneTouch Ultra Plus - 00353885012683 Catalog Number :

Device Description : OneTouch Ultra Plus™ Level 4 Control Solution for Use with OneTouch Ultra Plus F OneTouch Ultra Plus™ Level 4 Control Solution for Use with OneTouch Ultra Plus Flex™ Meter.

Device Class :

Duns Number: 480240820

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 75

OneTouch Ultrasoft - 00353885393102 Catalog Number : 020-393

Device Description : OneTouch Ultrasoft Lancets

Device Class :

Duns Number: 480240820

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

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