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Hardy Diagnostics

USA · Springboro

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Taiwan, Australia, Israel — 4 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

34listed device types

Class I 28Class II 6Class III 0

plus 135 registration records and 109 510(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

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 1 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States135 registration records, 109 510(k), 0 PMA, 2 excluded

Manufacturer names merged into this page: Hardy Diagnostics · HARDY DIAGNOSTICS

FDA 510(k) clearances by year

11995

41996

11997

31999

492000

92001

12006

12008

22010

12011

22015

12016

52017

32018

42019

12020

22023

22024

32025

12026

FDA listed device types

showing 8 of 34

Stains, Microbiologic 1Monitor, Microbial Growth 1Basic Fuchsin 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Slide Stainer, Automated 1Slides, Microscope 1Gbs Culture Media, Selective And Differential 1Culture Media, Enriched 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260842	HardyDisk AST Gepotidacin 10µg (GEP10)	2026-05-11
US	K253105	HardyDisk AST Cefiderocol 30µg (FDC30)	2025-11-20
US	K250956	HardyDisk AST Gepotidacin 10µg (GEP10)	2025-06-26

Hardy Diagnostics

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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