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LIFESCAN EUROPE GMBH

Switzerland · Zug

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Russia — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 3Class III 0

plus 6 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

5 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

5active device licences

Class II 3Class III 2

14 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

9active registrations

Class 2b 9

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States6 registration records, 4 510(k), 0 PMA, 3 excluded

Brazil0 confirmed, 1 excluded

Canada5 confirmed, 1 excluded

Manufacturer names merged into this page: LIFESCAN EUROPE GMBH

FDA 510(k) clearances by year

22015 · K151611

12017 · K163357

12020 · K193475

FDA listed device types

Glucose Dehydrogenase, Glucose 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1System, Test, Blood Glucose, Over The Counter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K193475	OneTouch Verio Reflect Blood Glucose Monitoring System	2020-02-14
US	K163357	OneTouch Via On-Demand Insulin Delivery System	2017-06-07
US	K151611	OneTouch Ultra Plus Flex Blood Glucose Monitoring System	2015-12-14
CA	4682	ULTRASOFT LANCETS	Class II
CA	27553	LANCING DEVICES	Class II
CA	83176	ONETOUCH SURESOFT SINGLE USE DISPOSABLE LANCING DEVICE	Class II

LIFESCAN EUROPE GMBH

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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