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) (6) Glucose dehydrogenase, glucose (LFR) (4) Glucose Dehydrogenase, Glucose (LFR) (2) Lancet, Blood (FMK) (2) System, Test, Blood Glucose, Over The Counter (NBW) (2)

Premarket Exempt

No Yes

Clear

One Touch SureSoft - 00353885006835 Catalog Number :

Device Description : One Touch SureSoft Single Use Disposable Lancing Device

Device Class :

Duns Number: 480240820

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : Yes

Device Count : 200

OneTouch SureSoft - 00353885006842 Catalog Number :

Device Description : One Touch SureSoft Single Use Disposable Lancing Device

Device Class :

Duns Number: 480240820

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : Yes

Device Count : 100

OneTouch Verio IQ - 00353885007702 Catalog Number : 022-267

Device Description : OneTouch Verio IQ Blood Glucose Monitoring System. For In vitro diagnostic use. OneTouch Verio IQ Blood Glucose Monitoring System. For In vitro diagnostic use. For self-testing

Device Class :

Duns Number: 480240820

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 1

OneTouch Verio IQ - 00353885007719 Catalog Number : 022-268

Device Description : OneTouch Verio IQ Blood Glucose Monitoring System. For in vitro diagnostic use. OneTouch Verio IQ Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing

Device Class :

Duns Number: 480240820

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 1

OneTouch Verio - 00353885007726 Catalog Number : 022-269

Device Description : OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTouch Verio Family of Meters

Device Class :

Duns Number: 480240820

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 10

OneTouch Verio - 00353885007733 Catalog Number : 022-270

Device Class :

Duns Number: 480240820

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 25

OneTouch Verio - 00353885007764 Catalog Number : 022-273

Device Description : OneTouch Verio®Level 3 Control Solution

Device Class :

Duns Number: 480240820

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 1

OneTouch Verio - 00353885007771 Catalog Number :

Device Description : OneTouch Verio®Level 4 Control Solution

Device Class :

Duns Number: 480240820

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 1

OneTouch Ultramini - 00353885008136 Catalog Number : 021-924

Device Description : OneTouch Ultramini Blood Glucose Monitoring Meter - Warranty replacement

Device Class : 2

Duns Number: 480240820

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

OneTouch Ultramini - 00353885008167 Catalog Number : 021-514

Device Description : OneTouch Ultramini Blood Glucose Monitoring Meter - Warranty replacement

Device Class : 2

Duns Number: 480240820

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

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