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Wallac, Inc.

Finland · Turku

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

40listed device types

Class I 19Class II 20Class III 1

plus 42 registration records and 24 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

41registered devices

Class I 28Class II 13

75 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

23active device licences

Class II 14Class III 9

51 including historic records

TWTaiwanTFDA

23valid device licences

Class I 7Class II 16

SGSingaporeHSA SMDR

15device registrations

CLASS B 2CLASS C 13

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

14active ARTG entries

IVD Class 1 3IVD Class 2 5IVD Class 3 6

HKHong KongMDACS

14valid listings

IVD C 14

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

36active registrations

Class 1 11Class 2a 13Class 2b 12

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 States42 registration records, 24 510(k), 0 PMA, 5 excluded

Brazil41 confirmed, 0 excluded

Canada23 confirmed, 0 excluded

Manufacturer names merged into this page: WALLAC OY

FDA 510(k) clearances by year

21992

31993

31994

11995

11999

22000

22001

22004

12005

12006

22008

12009

12010

12013

12014

FDA listed device types

showing 8 of 40

Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase 1Alpha-D-Galactosidase A (Gla) Newborn Screening Test System 1Calibrator, Secondary 1Radioimmunoassay, Thyroid-Stimulating Hormone 1Acid-Sphingomyelinase (Asm) Newborn Screening Test System 1ß-Glucocerebrosidase (Gba) Newborn Screening Test System 1Control, Hemoglobin, Abnormal 1Abnormal Hemoglobin Quantitation 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	DEN140010	PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM	2014-12-15
US	K131284	GSP NEONATAL BIOTINIDASE KIT	2013-11-14
US	K100682	GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U	2010-07-23
BR	10298910058	SOLUCAO PADRAO EUROPIO DELFIA	Class I
BR	10298910033	SOLUCAO DE LAVAGEM CONCENTRADA DELFIA	Class I
BR	10298910034	SOLUÇÃO ENHANCEMENT DELFIA	Class I
CA	19073	DELFIA HTSH ASSAY	Class II
CA	35748	DELFIA ALPHA FETO PROTEIN (HAFP) ASSAY	Class III
CA	35749	DELFIA CEA ASSAY	Class III