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DiaSource ImmunoAssays, SA

Belgium · Louvain-La-Neuve Brabant Wallon

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

19listed device types

Class I 16Class II 3Class III 0

plus 19 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

19registered devices

Class II 19

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

20active device licences

Class II 20

27 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

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 States19 registration records, 1 510(k), 0 PMA

Brazil19 confirmed, 0 excluded

Canada20 confirmed, 0 excluded

Manufacturer names merged into this page: DiaSource ImmunoAssays, SA · DIASOURCE IMMUNOASSAYS S.A. · DIASOURCE IMMUNOASSAYS S.A · DIASOURCE IMMUNOASSAYS SA

FDA 510(k) clearances by year

12013 · K123364

FDA listed device types

showing 8 of 19

Immunoassay, Insulin-Like Growth Factor Binding Protein-1 1Radioimmunoassay, Progesterone 1Radioimmunoassay, Immunoreactive Insulin 1Radioimmunoassay, 17-Hydroxyprogesterone 1Radioimmunoassay, Estradiol 1Radioimmunoassay, Glucagon 1Test, Follicle Stimulating Hormone (Fsh), Over The Counter 1Radioimmunoassay, Estrone 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K123364	25OH VITAMIN D TOTAL ELISA TEST	2013-07-15
BR	80564740027	SEROTONINA ELISA	Class II
BR	10337680173	ESTRADIOL - ELISA	Class II
BR	80564740019	HGH ELISA	Class II
CA	93665	FT4 RIA	Class II
CA	93666	FT3 RIA	Class II
CA	98575	17OH-PROGESTERONE ELISA	Class II

DiaSource ImmunoAssays, SA

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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