Fujirebio Europe N.V.

Belgium BE-MF-000001792 Last updated 25 Oct 2026

Devices: 18
Registries: EUDAMEDFDA
FDA recalls: 0

Catalogue18

INNO-LiPA CFTR Deletions + 6 Strips <10T, CE> Ref 80578

Class C EUDAMED Active
INNO-LiPA HCV 2.0 Amp <20T, CE> Ref 81548

Class C EUDAMED Active
INNO-LiPA CFTR OneAmp Kit <20T, CE> Ref 80596

Class C EUDAMED Active
Lumipulse G pTau 217 Plasma Immunoreaction Cartridges <3x14T, CE> Ref 81544

Class B EUDAMED Active
LiRAS for LiPA HBV v1 <CE> Ref 81387

Class A EUDAMED Active
INNO-LiPA HBV Genotyping <20T, CE> Ref 80691

Class C EUDAMED Active
INNO-LiPA HPV Genotyping Extra II <20T, CE> Ref 81534

Class C EUDAMED Active
INNO-LiPA CFTR19 Strips <20T, CE> Ref 80580

Class C EUDAMED Active
INNO-LiPA CFTR17 + Tn Strips <20T, CE> Ref 80581

Class C EUDAMED Active
INNO-LiPA CFTR Buffer Kit <20T, CE> Ref 80595

Class C EUDAMED Active
INNO-LiPA HCV 2.0 Control <3T, CE> Ref 81549

Class C EUDAMED Active
INNO-LiPA HCV 2.0 Genotyping <20T, CE> Ref 81547

Class C EUDAMED Active
INNO-LiPA CFTRiage Strips <20T, CE> Ref 80577

Class C EUDAMED Active
INNO-LiPA CFTR Extra Strips <10T, CE> Ref 80582

Class C EUDAMED Active
INNO-LiPA HPV Genotyping Extra II Amp <20T, CE> Ref 81533

Class C EUDAMED Active
INNO-LiPA CFTR Italian Regional Strips <10T, CE> Ref 80579

Class C EUDAMED Active
Lumipulse pTau 217 Plasma Controls <2x2C, CE> Ref 81546

Class B EUDAMED Active
Lumipulse G pTau 217 Plasma Calibrators <1x5C, CE> Ref 81545

Class B EUDAMED Active

About

Fujirebio is an R&D-driven company constantly developing new technologies and unique biomarkers with high clinical value. Our group mission is to create new value in healthcare and thereby contribute to human health and the future of medical care.

From the manufacturer's own website. Source

Information

Country: Belgium(from SRN)
Address: 6, Technologiepark , Gent, Belgium
Website: www.fujirebio.com
LinkedIn: linkedin.com/company/fujirebioeurope
Email: [email protected]
Phone: +3293291329
PRRC contact: Marijke De Roeve
EUDAMED SRN: BE-MF-000001792
FDA FEI number: 3002608770

Catalogue18

INNO-LiPA CFTR Deletions + 6 Strips <10T, CE> Ref 80578

INNO-LiPA HCV 2.0 Amp <20T, CE> Ref 81548

INNO-LiPA CFTR OneAmp Kit <20T, CE> Ref 80596

Lumipulse G pTau 217 Plasma Immunoreaction Cartridges <3x14T, CE> Ref 81544

LiRAS for LiPA HBV v1 <CE> Ref 81387

INNO-LiPA HBV Genotyping <20T, CE> Ref 80691

INNO-LiPA HPV Genotyping Extra II <20T, CE> Ref 81534

INNO-LiPA CFTR19 Strips <20T, CE> Ref 80580

INNO-LiPA CFTR17 + Tn Strips <20T, CE> Ref 80581

INNO-LiPA CFTR Buffer Kit <20T, CE> Ref 80595

INNO-LiPA HCV 2.0 Control <3T, CE> Ref 81549

INNO-LiPA HCV 2.0 Genotyping <20T, CE> Ref 81547

INNO-LiPA CFTRiage Strips <20T, CE> Ref 80577

INNO-LiPA CFTR Extra Strips <10T, CE> Ref 80582

INNO-LiPA HPV Genotyping Extra II Amp <20T, CE> Ref 81533

INNO-LiPA CFTR Italian Regional Strips <10T, CE> Ref 80579

Lumipulse pTau 217 Plasma Controls <2x2C, CE> Ref 81546

Lumipulse G pTau 217 Plasma Calibrators <1x5C, CE> Ref 81545

About

Information