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Fujirebio Inc.

Japan · Tokyo

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Israel — 7 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

11listed device types

Class I 3Class II 8Class III 0

plus 7 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 3Class II 2

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

2active device licences

Class III 1Class IV 1

10 including historic records

TWTaiwanTFDA

9valid device licences

Class II 9

SGSingaporeHSA SMDR

4device registrations

CLASS C 2CLASS D 2

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

IVD import 2

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States7 registration records, 0 510(k), 0 PMA, 9 excluded

Brazil5 confirmed, 2 excluded

Canada2 confirmed, 3 excluded

Manufacturer names merged into this page: Fujirebio Inc. · FUJIREBIO INC.

FDA listed device types

showing 8 of 11

Single (Specified) Analyte Controls (Assayed And Unassayed) 1Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1Multi-Analyte Controls Unassayed 1Enzyme Linked Immunoabsorption Assay, Treponema Pallidum 1Immunoassay Blood Test For Amyloid Pathology Assessment 1Antigen, Inflammatory Response Marker, Sepsis 1Procalcitonin Assay 1Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80102513263	LUMIPULSE G SUBSTRATE SOLUTION	Class I
BR	80102513264	LUMIPULSE G SPECIMEN DILUENT 1	Class I
BR	80102513269	LUMIPULSE G DILUTION CARTRIDGES	Class I
CA	2378	SERODIA MHA-TP TEST KIT	Class III
CA	105716	PK CMV-PA SYSTEM	Class IV

Fujirebio Inc.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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