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THERADIAG SA

France · Croissy Beaubourg

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

11listed device types

Class I 2Class II 9Class III 0

plus 4 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

23active device licences

Class II 23

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

Canada23 confirmed, 0 excluded

Manufacturer names merged into this page: THERADIAG · THERADIAG SA

FDA listed device types

showing 8 of 11

Antinuclear Antibody, Antigen, Control 1Anti-Rnp Antibody, Antigen And Control 1Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls 1Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) 1Extractable Antinuclear Antibody, Antigen And Control 1Anti-Ribosomal P Antibodies 1Test System, Antineutrophil Cytoplasmic Antibodies (Anca) 1Anti-Sm Antibody, Antigen And Control 1

Market	Identifier	Name	Class / date
CA	82942	SYSTEME FIDIS (CYTOMETRE DE FLUX)	Class II
CA	82943	IMMUNO-TROL CONNECTIVE 1	Class II
CA	93262	LISA-TRACKER GAMME ETANERCEPT	Class II

THERADIAG SA

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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