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Elitechgroup, Inc.

USA · Logan

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 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

26listed device types

Class I 15Class II 11Class III 0

plus 24 registration records and 18 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 2Class II 3

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

12 including historic records

TWTaiwanTFDA

4valid device licences

Class I 3Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

31active ARTG entries

IVD Class 1 5IVD Class 2 5IVD Class 3 20IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 3

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 States24 registration records, 18 510(k), 0 PMA, 7 excluded

Brazil5 confirmed, 0 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: ELITechGroup Inc · ELITECHGROUP INC.

FDA 510(k) clearances by year

62011

22012

22013

22014

22015

12016

12017

22018

FDA listed device types

showing 8 of 26

Stains, Microbiologic 1Cytocentrifuge 1Osmometer For Clinical Use 1Enzymatic Esterase--Oxidase, Cholesterol 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Device, Automated Sedimentation Rate 1General Purpose Reagent 1Multi-Analyte Controls, All Kinds (Assayed) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K180559	HSV 1 & 2 ELITe MGB Kit; ELITe InGenius	2018-10-29
US	K180627	Macroduct Advanced Model 3710	2018-07-27
US	K171401	ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1	2017-07-11
BR	80657030016	SWEAT CHEK	Class II
BR	80615950031	ChloroChek Reagent Set	Class I
BR	80615950053	Wescor Sweat Controls	Class II

Elitechgroup, Inc.

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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