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Diagam S.A.

Belgium · Ghislenghien · www.diagam.com

✓ Record-verifiedregistrations found in 5 marketsEU SRN BE-MF-000022993

This company has registrations in European Union, United States, Brazil, Singapore, Australia — 5 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. 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

≥300UDI-DI device records

IVD general 300

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

3listed device types

Class I 1Class II 2Class III 0

plus 3 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

37registered devices

Class II 37

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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IVD Class 2 3

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.

European Union959 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States3 registration records, 0 510(k), 0 PMA

United Kingdom0 confirmed, 1 excluded

Brazil37 confirmed, 1 excluded

Manufacturer names merged into this page: DIAGAM S.A.

Regulatory identity

EU manufacturer SRN: BE-MF-000022993

Registration details (sample)

Market	Identifier	Name	Class / date
EU	05415168017565	Albumin urine & CSF	IVD general
EU	05415168017558	Albumin urine & CSF	IVD general
EU	05415168005357	immunoglobulins G urine & CSF	IVD general
EU	05415168004039	CRP control H	IVD general
BR	81546350082	Alfa-1-antitripsina ADV	Class II
BR	81546350083	Alfa-1-antitripsina ATE	Class II
BR	81546350090	Beta-2-microglobulina	Class II

Diagam S.A.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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