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SCIMEDX CORPORATION

USA · Dover

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Australia, Israel — 7 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

14510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

11registered devices

Class II 11

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

24active device licences

Class II 23Class III 1

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

12device registrations

CLASS B 12

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

4active ARTG entries

IVD Class 1 1IVD Class 2 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States0 registration records, 14 510(k), 0 PMA, 1 excluded

Brazil11 confirmed, 0 excluded

Canada24 confirmed, 0 excluded

Manufacturer names merged into this page: SCIMEDX CORPORATION · SCIMEDX CORP

Registration details (sample)

Market	Identifier	Name	Class / date
US	K011348	PHASE II GBM IGG ANTIBODY EIA TEST	2001-06-25
US	K011082	TPO IGG ANTIBODY EIA TEST	2001-06-06
US	K010625	EUROSPITAL EU-TTG IGA UMANA	2001-04-24
BR	10225960034	LEGIONELLA DFA	Class II
BR	10225960022	ANTICORPOS ANTI-nDNA IMUNOFLUORESCENCIA	Class II
BR	10225960020	ANTICORPOS ANTI-MITOCONDRIA IMUNOFLUORESCENCIA	Class II
CA	25450	SCANLISA ANTI-THYROID PEROXIDASE IGG ASSAY	Class II
CA	25455	ANTI-N DNA ASSAY	Class II
CA	36410	H.PYLORI EIA IGG TEST KIT	Class II

SCIMEDX CORPORATION

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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