HomeBelgiumFujirebio Europe N.V.

Fujirebio Europe N.V.

Belgium · Gent
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Australia, Hong Kong, 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
5listed device types
Class I 2Class II 3Class III 0
plus 5 registration records and 0 510(k), 6 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
11registered devices
Class I 1Class II 10
17 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 1Class III 1Class IV 1
6 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
8device registrations
CLASS C 4CLASS D 4
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
IVD import 3
AUAustraliaTGA ARTG
3active ARTG entries
IVD Class 1 2IVD Class 3 1
HKHong KongMDACS
4valid listings
IVD C 1IVD D 3
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
4active registrations
Class 2a 1Class 2b 2Class 3 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 States5 registration records, 0 510(k), 6 PMA, 9 excluded
Brazil11 confirmed, 2 excluded
Canada3 confirmed, 3 excluded
Manufacturer names merged into this page: Fujirebio Europe N.V. · FUJIREBIO EUROPE N.V.

Company information

Country
Belgium
City
Gent

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA listed device types

Single (Specified) Analyte Controls (Assayed And Unassayed) 1Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1Cytokeratin Fragments 21-1 Eia Kit 1Immunoassay Blood Test For Amyloid Pathology Assessment 1Assay, Genotyping, Hepatitis C Virus 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80102513713Família Lumipulse G pTauClass II
BR80102513714Familia Lumipulse G NfLClass II
BR80102512521Aß(1-42) CAL-RVCClass II
CA28374INNO-LIA ANA UPDATEClass II
CA38344INNO-LIA HVC AB III UPDATEClass IV
CA11119INNO-LIPA HIV-1 RT MUTATION AMPLIFICATION AND HIV - 1 RT PRIMERClass III

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