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Abaxis

USA · Union City CA · www.abaxis.com

✓ Record-verifiedregistrations found in 9 marketsEU SRN US-MF-000021651

This company has registrations in European Union, United States, United Kingdom, Canada, 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

3UDI-DI device records

IVD A 3

USUnited StatesFDA openFDA

28listed device types

Class I 11Class II 17Class III 0

plus 16 registration records and 20 510(k)

UKUnited KingdomMHRA PARD

2registered device records

IVD A 1IVD general 1

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

1active device licences

Class II 1

4 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

4device registrations

CLASS B 1CLASS C 3

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

1registrations

RURussiaRoszdravnadzor

2active registrations

Class 1 1Class 2a 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.

European Union3 raw hits, 0 excluded, 3 confirmed

United States16 registration records, 20 510(k), 0 PMA

United Kingdom2 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: ABAXIS, INC. · ABAXIS INC.

Regulatory identity

EU manufacturer SRN: US-MF-000021651
EU authorised representative: ABAXIS Europe GmbH
UK responsible person: MDSS-UK RP LIMITED

FDA 510(k) clearances by year

11994

21995

11996

21999

12001

12002

32003

12004

12005

12009

12010

22012

22013

12021

FDA listed device types

showing 8 of 28

Nadh Oxidation/Nad Reduction, Alt/Sgpt 1Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl 1Acid, Lactic, Enzymatic Method 1Analyzer, Chemistry, Centrifugal, For Clinical Use 1Kinetic Method, Gamma-Glutamyl Transpeptidase 1Phosphomolybdate (Colorimetric), Inorganic Phosphorus 1Enzymatic Esterase--Oxidase, Cholesterol 1Atp And Creatine Kinase (Enzymatic), Creatine 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	EABA11000000EI1	Piccolo Xpress	IVD A
EU	+EABA11000000ER1	Piccolo Xpress	IVD A
EU	EABA11000000E1	Piccolo Xpress	IVD A
UK	62181	Piccolo Xpress chemistry analyzer	IVD A
UK	63832	PICCOLO® AmLyte 13	IVD general
US	K200865	Piccolo Potassium Test System	2021-10-20
US	K130113	PICCOLO LACTATE TEST SYSTEM	2013-03-11
US	K130200	PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM	2013-02-15
CA	72181	PICCOLO BLOOD CHEMISTRY ANALYZER	Class II