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HORIBA ABX SAS

France · Montpellier

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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

63listed device types

Class I 25Class II 38Class III 0

plus 69 registration records and 36 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

95registered devices

Class I 20Class II 75

105 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

3active device licences

Class II 3

22 including historic records

TWTaiwanTFDA

7valid device licences

Class I 7

SGSingaporeHSA SMDR

8device registrations

CLASS B 8

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

IVD import 4

AUAustraliaTGA ARTG

1active ARTG entries

IVD Class 1 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

9registrations

RURussiaRoszdravnadzor

15active registrations

Class 1 4Class 2a 10Class 2b 1

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 States69 registration records, 36 510(k), 0 PMA, 2 excluded

Brazil95 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: HORIBA ABX SAS

FDA 510(k) clearances by year

52005

62006

52007

32008

12009

22011

12012

12013

22014

12015

12017

32019

32020

12021

12024

FDA listed device types

showing 8 of 63

Counter, Differential Cell 1Igm, Antigen, Antiserum, Control 1Alkaline Picrate, Colorimetry, Creatinine 1Calibrator, Secondary 1Calibrator, Primary 1Electrode, Ion-Specific, Chloride 1System, Test, Rheumatoid Factor 1Calibrator For Hemoglobin And Hematocrit Measurement 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232946	Yumizen H2500	2024-05-21
US	K193649	Yumizen C1200 Creatinine PAP	2021-05-10
US	K193525	Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M	2020-06-26
BR	10347320004	ABX CLEANER	Class I
BR	10347320008	ABX MINILYSE LMG	Class I
BR	10347320011	ABX DILUENT	Class I
CA	72989	C-REACTIVE PROTEIN CONTROL	Class II
CA	93350	PENTRA C200	Class II
CA	95200	PENTRA DX NEXUS	Class II

HORIBA ABX SAS

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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