FDA.reportPublic FDA data

LIFESCAN EUROPE GMBH

Matched from indexed company URL: LifeScan Europe GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30083820073008382007LIFESCAN EUROPE GMBH1N2026-01-01Dammstrasse 19 CH Zug CH 6300

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00353885000512OneTouch Ultramini - OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip+1(800)227-8862XX@XX.XX
00353885001311OneTouch Ultramini - OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip+1(800)227-8862XX@XX.XX
00353885002684OneTouch Ultramini - OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip+1(800)227-8862XX@XX.XX
00353885007719OneTouch Verio IQ - OneTouch Verio IQ Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing+1(888)567-3003XX@XX.XX
00353885007726OneTouch Verio - OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTouch Verio Family of Meters+1(888)567-3003XX@XX.XX
00353885007733OneTouch Verio - OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTouch Verio Family of Meters+1(888)567-3003XX@XX.XX
00353885008723OneTouch Verio - OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing For Single Patient use only.+1(888)567-3003XX@XX.XX
00353885008853OneTouch Ultra2 - OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip+1(800)227-8862XX@XX.XX

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1165592010717662K193475OneTouch Verio Reflect Blood Glucose Monitoring SystemNBW2020-02-14
1165591052312403K151611OneTouch Ultra Plus Flex Blood Glucose Monitoring SystemNBW2015-12-14
1165591090526886K150214OneTouch Verio Flex Blood Glucose Monitoring SystemNBW2015-07-31
1165591808607390K132618ONETOUCH REVEALMRZ2013-12-16
1165591868326195K131363ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEMNBW2013-08-30
1165591737007801K120708ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEMNBW2013-02-07
1165591446927942K120558ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATIONNBW2013-02-07
1165591188894001K110637ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEMLFR2011-09-07
1165591311250251K103553LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTIONJJX2011-02-10
1165591230435908K082590SYMPHONY METER REMOTELZG2008-12-17
1165591760959582K072543ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEMNBW2007-10-05
1165591764149760K061118ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEMNBW2006-05-19
1165591360038300K053529ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEMNBW2006-01-17
1165591579494642K043197ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEMCGA2005-05-20
1165591854211532

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW92020-02-14
MRZ12013-12-16
LFR12011-09-07
JJX12011-02-10
LZG12008-12-17
CGA12005-05-20

PMN#

GUDID#

143 records. Showing 1-40. Next