FDA.reportPublic FDA data

LIFESCAN EUROPE GMBH

Matched from indexed company URL: LIFESCAN, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30083820073008382007LIFESCAN EUROPE GMBH1N2026-01-01Dammstrasse 19 CH Zug CH 6300
30096983882939301Lifescan, Inc.1Y2026-01-0175 Valley Stream Parkway Malvern PA US 19355
30423018473042301847LifeScan U.S. LLC1Y2026-01-0175 Valley Stream Pkwy Malvern PA US 19355

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
00353885011761OneTouch Verio Flex - OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip. Not for Resale or Reimbursement+1(888)567-3003XX@XX.XX
00353885012614OneTouch Verio - OneTouch Verio Test Strips. For Blood Glucose testing with OneTouch Verio Family of meters. For in vitro diagnostic use. For self testing.1 888 567-3003xx@xx.xx
00353885012638OneTouch Ultra Plus - OneTouch Ultra® Plus strips work with OneTouch Ultra Plus Flex(TM) meter.1 888 567-3003xx@xx.xx
00353885012782OneTouch Verio - OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. For in vitro diagnostic use. For self-testing1 888 567-3003XX@XX.XX

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1418571826121158K984527IN TOUCH DIABETES MANAGEMENT SOFTWARECGA1999-04-29
1165592010717662K193475OneTouch Verio Reflect Blood Glucose Monitoring SystemNBW2020-02-14
1165591052312403K151611OneTouch Ultra Plus Flex Blood Glucose Monitoring SystemNBW2015-12-14
1418571307694400K151611OneTouch Ultra Plus Flex Blood Glucose Monitoring SystemNBW2015-12-14
1165591090526886K150214OneTouch Verio Flex Blood Glucose Monitoring SystemNBW2015-07-31
1418571285009360K150214OneTouch Verio Flex Blood Glucose Monitoring SystemNBW2015-07-31
1418571409172684K132618ONETOUCH REVEALMRZ2013-12-16
1165591808607390K132618ONETOUCH REVEALMRZ2013-12-16
1418571464549199K131363ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEMNBW2013-08-30
1165591868326195K131363ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEMNBW2013-08-30
1165591737007801K120708ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEMNBW2013-02-07
1165591446927942K120558ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATIONNBW2013-02-07
1418572033655001K120558ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATIONNBW2013-02-07
1165591188894001K110637ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEMLFR2011-09-07
1418571378315727K110637ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEMLFR2011-09-07
1165591311250251K103553LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTIONJJX2011-02-10
3455071650514152K103553LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTIONJJX2011-02-10
1418571662357534K103553LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTIONJJX2011-02-10
1165591230435908K082590SYMPHONY METER REMOTELZG2008-12-17
1418571604963477K082590SYMPHONY METER REMOTELZG2008-12-17
1418571137032868K081318ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAMNBW2008-06-09
3455071305542669K072543ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEMNBW2007-10-05
1418571389353147K072543ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEMNBW2007-10-05
1165591760959582K072543ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEMNBW2007-10-05
1418571339566609K061118ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEMNBW2006-05-19
3455071368966846K061118ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEMNBW2006-05-19
1165591764149760K061118ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEMNBW2006-05-19
3455071259088815K053529ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEMNBW2006-01-17
1165591360038300K053529ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEMNBW2006-01-17
1418571719289373K053529ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEMNBW2006-01-17
1418571413476107K043197ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEMCGA2005-05-20
1165591579494642K043197ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEMCGA2005-05-20
3455072007160175K043197ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEMCGA2005-05-20
1418571312054419
1165591854211532

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW202020-02-14
CGA42005-05-20
JJX32011-02-10
MRZ22013-12-16
LFR22011-09-07
LZG22008-12-17

PMN#

46 records. Showing 1-40. Next

GUDID#

82 records. Showing 1-40. Next