Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008382007

FEI Number

3008382007

Entity Name

LIFESCAN EUROPE GMBH

City/State/Country

CH Zug, CH

Establishment Address

Dammstrasse 19, CH Zug 6300, CH

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

LifeScan Europe, GmbH (Owner Number: 10032336)

Owner / Operator Contact Address

Beechwood Park North, Inverness, GB-HLD IV2 3ED, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K110637

PMA Number

N/A

All Registered Proprietary Names

OneTouch Verio Blood Glucose Monitoring System OneTouch Verio Test Strips OneTouch Verio Control Solution OneTouch Verio Meter OneTouch SureSoft Lancet OneTouch UltraSoft Lancing Device and Lancets OneTouch FinePoint Lancets OneTouch Lancing Device OneTouch Delica Lancing Device and Lancets OneTouch Delica Plus Lancing Device and Lancets OneTouch Delica Safety Lancing Device and Lancets OneTouch Verio Reflect Blood Glucose Monitoring System OneTouch Solutions OneTouch Ultra Plus Control Solution OneTouch Ultra Plus Test Strips OneTouch Ultra Plus Flex Meter OneTouch Verio IQ Blood Glucose Monitoring System OneTouch Verio Test Strips OneTouch Verio Control Solutions OneTouch Verio IQ Meter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2013-09-18
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2013-09-18
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2011-04-12
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2020-02-25
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-02-29
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-02-29
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-09-22
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2011-09-22

Official Correspondent

Jennifer Mackenzie

US Agent Details

Amber Wingler Business: LIFESCAN US LLC Email: awingler@lifescan.com Phone: (484) 3207594

Related Public Records

Same Entity

LifeScan Europe, GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K973662	Boehringer Mannheim Corp.	ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS	1997-12-15
K150396	Apex BioTechnology Corp.	Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips	2015-10-14
K150833	Andon Health Co, Ltd.	iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System	2015-12-04
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06	Abbott Laboratories Medisense Products	2	Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06	Abbott Laboratories Medisense Products	2	Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

Similar Registrations

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1810909	Ascensia Diabetes Care US Inc.	Valhalla, NY, US
2954323	ABBOTT DIABETES CARE INC.	ALAMEDA, CA, US
3003741676	ANDON HEALTH CO., LTD	TIANJIN, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008382007. Last updated year: 2026. Please use registration number 3008382007 when referencing this establishment in official correspondence.