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Fujirebio Diagnostics, Inc.

USA · Malvern

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Israel — 6 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

27listed device types

Class I 4Class II 20Class III 0unclassified 3

plus 39 registration records and 48 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

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

14active device licences

Class II 8Class III 5Class IV 1

18 including historic records

TWTaiwanTFDA

29valid device licences

Class II 29

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

IVD import 3

AUAustraliaTGA ARTG

pendingnot queried

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 States39 registration records, 48 510(k), 0 PMA, 4 excluded

Brazil1 confirmed, 2 excluded

Canada14 confirmed, 2 excluded

Manufacturer names merged into this page: Fujirebio Diagnostics, Inc. · Fujirebio Diagnostics, AB · Fujirebio Diagnostics AB · FUJIREBIO DIAGNOSTICS, INC. · FUJIREBIO DIAGNOSTICS AB

FDA 510(k) clearances by year

11989

12002

32004

22005

12006

22007

42008

12009

32010

62011

12013

22014

22015

52016

62017

22019

32020

12022

22025

FDA listed device types

showing 8 of 27

Sirolimus Test System 1Antigens, Ha, Treponema Pallidum 1Calibrator, Secondary 1Cytokeratin Fragments 21-1 Eia Kit 1Ovarian Adnexal Mass Assessment Score Test System 1System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer 1Test, Natriuretic Peptide 1Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250925	ADVIA Centaur Cytokeratin Fragment 21-1	2025-12-16
US	K242706	Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio	2025-05-16
US	DEN200072	Lumipulse G ß-Amyloid Ratio (1-42/1-40)	2022-05-04
BR	80102513268	LUMIPULSE G WASH SOLUTION	Class I
CA	9442	CYFRA 21-1 RIA	Class II
CA	9445	TRUQUANT 0V2	Class II
CA	9452	TRUQUANT GI	Class II

Fujirebio Diagnostics, 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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