Microlife AG

Switzerland · Widnau · www.microlife.com

✓ Record-verifiedregistrations found in 9 marketsEU SRN TW-MF-000010688

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, Australia, Israel, Russia — 9 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

188UDI-DI device records

Class I 96Class IIa 92

USUnited StatesFDA openFDA

7listed device types

Class I 0Class II 6Class III 0unclassified 1

plus 79 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

9registered device records

Class I 1Class IIa 8

BRBrazilANVISA

10registered devices

Class II 10

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

19active device licences

Class II 19

40 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

13device registrations

CLASS B 13

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

13active ARTG entries

Class I 5IIa 8

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

16active registrations

Class 1 2Class 2a 14

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.

European Union188 raw hits, 0 excluded, 188 confirmed

United States79 registration records, 16 510(k), 0 PMA, 6 excluded

United Kingdom9 confirmed, 0 excluded

Brazil10 confirmed, 0 excluded

Canada19 confirmed, 0 excluded

Manufacturer names merged into this page: MICROLIFE CORP. · MICROLIFE CORPORATION

Regulatory identity

EU manufacturer SRN: TW-MF-000010688
EU authorised representative: Microlife UAB
UK responsible person: Microlife Health Management Ltd

FDA 510(k) clearances by year

32000

32002

22003

12004

22007

12008

12013

12025

22026

FDA listed device types

Pad, Heating, Powered 1Flowmeter, Blood, Cardiovascular 1System, Measurement, Blood-Pressure, Non-Invasive 1Meter, Peak Flow, Spirometry 1Computer, Oxygen-Uptake 1Continuous Measurement Thermometer 1Device, Fertility Diagnostic, Proceptive 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04719003408367	Microlife	Class IIa
EU	04719003070526	—	Class IIa
EU	04719003070519	—	Class IIa
EU	04719003933425	Microlife	Class I
UK	45617	Microlife	Class IIa
UK	36888	Microlife	Class IIa
UK	34978	Microlife	Class I
US	K261082	Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)	2026-07-23
US	K253180	Microlife Digital Peak Flow Meter, Model PF200B (PF200B)	2026-06-23
US	K251120	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B)	2025-08-06
BR	80560319030	Termômetro sem contato com bluetooh - NC 150 BT	Class II
BR	80560319012	Microlife WatchBP Home A	Class II
BR	80560319007	MICROLIFE BP W100	Class II
CA	35060	AUTOMATIC INFLATION BLOOD PRESSURE MONITOR	Class II
CA	35061	MANUAL INFLATION BLOOD PRESSURE MONITOR	Class II
CA	35063	WRIST WATCH BLOOD PRESSURE MONITOR	Class II

Microlife AG

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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