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CEPHEID AB

USA · Sunnyvale

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

37listed device types

Class I 8Class II 25Class III 2unclassified 2

plus 155 registration records and 62 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

15registered devices

Class I 9Class II 6

48 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

9active device licences

Class II 3Class III 6

36 including historic records

TWTaiwanTFDA

20valid device licences

Class I 3Class II 11Class III 6

SGSingaporeHSA SMDR

26device registrations

CLASS B 1CLASS C 18CLASS D 7

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

IVD import 3

AUAustraliaTGA ARTG

25active ARTG entries

IVD Class 1 4IVD Class 2 3IVD Class 3 16IVD Class 4 2

HKHong KongMDACS

22valid listings

IVD B 3IVD C 19

ILIsraelAMAR

54registrations

RURussiaRoszdravnadzor

5active registrations

Class 2b 2Class 3 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 States155 registration records, 62 510(k), 0 PMA

Brazil15 confirmed, 1 excluded

Canada9 confirmed, 0 excluded

Manufacturer names merged into this page: CEPHEID · Cepheid · CEPHEID AB

FDA 510(k) clearances by year

22006

22007

22008

32009

22010

22011

42012

22013

22014

32015

42016

42017

52018

32019

32022

52023

42024

62025

42026

FDA listed device types

showing 8 of 37

Assay, Enterovirus Nucleic Acid 1System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony 1Microbial Nucleic Acid Storage And Stabilization Device 1Respiratory Virus Panel Nucleic Acid Assay System 1Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents 1Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test 1Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections 1System, Test, Tumor Marker, Monitoring, Bladder 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261362	Xpert Hemorrhagic Fever	2026-08-07
US	K261867	Xpert Carba-R	2026-07-02
US	K253653	Xpert Hemorrhagic Fever	2026-02-20
BR	81062710044	Xpert® Swab Specimen Collection Kit	Class I
BR	81062710045	Família GeneXpert Dx System	Class II
BR	81062710032	Xpert Nasal Sample Collection Kit for Viruses	Class I
CA	60459	SMART CYCLER	Class III
CA	75145	SMART GBS ASSAY	Class III
CA	77153	XPERT EV	Class III