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LABSYSTEMS DIAGNOSTICS OY

Finland · Vantaa

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia — 5 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

4listed device types

Class I 4Class II 0Class III 0

plus 4 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 3Class II 4

9 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

4active device licences

Class II 3Class III 1

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IVD Class 2 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 States4 registration records, 0 510(k), 0 PMA, 1 excluded

Brazil7 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: LABSYSTEMS DIAGNOSTICS · LABSYSTEMS DIAGNOSTICS OY

FDA listed device types

Station, Pipetting And Diluting, For Clinical Use 1Analyzer, Chemistry, Micro, For Clinical Use 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	81541770002	Família Vitamin C	Class II
BR	81210940001	SISTEMA NS2400	Class II
BR	81541770001	Família Vitamin A&E	Class II
CA	72753	MYSET OVULATION TEST	Class II
CA	72754	MYSET PREGNANCY TEST	Class II
CA	72755	MYSET MENOPAUSE TEST	Class II

LABSYSTEMS DIAGNOSTICS OY

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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