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DyonCalpro

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: DYONMED SA
Manufacturer SRN: GR-MF-000033588
UDI-DI: 05200251202061
Basic UDI-DI: B-05200251202061
Reference: DNCT101
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:48

Manufacturer products View details

04560189213616

AIA-PACK KL-6 CONTROL SET

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189213616
Basic UDI-DI: B-04560189213616
Reference: 0025444
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

04560189213609

ST AIA-PACK KL-6 SAMPLE DILUTING SOLUTION

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189213609
Basic UDI-DI: B-04560189213609
Reference: 0025544
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

04560189213593

ST AIA-PACK KL-6 CALIBRATOR SET

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189213593
Basic UDI-DI: B-04560189213593
Reference: 0025344
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

04560189213548

AIA-PACK Presepsin CONTROL SET

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189213548
Basic UDI-DI: B-04560189213548
Reference: 0025442
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

04560189213531

ST AIA-PACK Presepsin SAMPLE DILUTING SOLUTION

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189213531
Basic UDI-DI: B-04560189213531
Reference: 0025542
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

04560189213524

ST AIA-PACK Presepsin CALIBRATOR SET

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189213524
Basic UDI-DI: B-04560189213524
Reference: 0025342
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

04560189212213

AIA-PACK Cystatin C CONTROL SET

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189212213
Basic UDI-DI: B-04560189212213
Reference: 0025417
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

04560189212206

ST AIA-PACK Cystatin C SAMPLE DILUTING SOLUTION

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189212206
Basic UDI-DI: B-04560189212206
Reference: 0025517
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

04560189212190

ST AIA-PACK Cystatin C CALIBRATOR SET

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189212190
Basic UDI-DI: B-04560189212190
Reference: 0025317
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

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

81544

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Fujirebio Europe N.V.
Manufacturer SRN: BE-MF-000001792
UDI-DI: 05414470815449
Basic UDI-DI: 541447003155
Reference: 81544
EMDN: W0102019017
EMDN description: PHOSPHORYLATED TAU (PTAU)
First on market country: Belgium
Authorised representative: -
Last updated: 01.08.2026 20:16

Manufacturer products View details

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

IVD Class BNot specifiedOn the marketSingle use

Manufacturer: Fujirebio Europe N.V.
Manufacturer SRN: BE-MF-000001792
UDI-DI: 05414470815456
Basic UDI-DI: 541447003155
Reference: 81545
EMDN: W0102019017
EMDN description: PHOSPHORYLATED TAU (PTAU)
First on market country: Belgium
Authorised representative: -
Last updated: 01.08.2026 20:16

Manufacturer products View details

Cystatin C Kit (Latex Immunoturbidimetric Method)

105-004638-00、105-004639-00、105-004640-00、105-004647-00、105-004651-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904053608
Basic UDI-DI: 69449040004MCysC*******Q4
Reference: 105-004638-00
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

IDK® Zonulin ELISA

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598156005
Basic UDI-DI: B-04050598156005
Reference: K 5600
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

β2-Mikroglobulin ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598162105
Basic UDI-DI: B-04050598162105
Reference: K 6210
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

β-Defensin 2 ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598165007
Basic UDI-DI: B-04050598165007
Reference: K 6500
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

L-Citrullin

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598166004
Basic UDI-DI: B-04050598166004
Reference: K 6600
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

α2-Makroglobulin ELISA

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598166103
Basic UDI-DI: B-04050598166103
Reference: K 6610
EMDN: W0102019003
EMDN description: A2-MACROGLOBULIN
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

α1-Mikroglobulin ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598167100
Basic UDI-DI: B-04050598167100
Reference: K 6710
EMDN: W0102019004
EMDN description: A1-MICROGLOBULIN
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

IDK® α1-Antitrypsin ELISA

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598167506
Basic UDI-DI: B-04050598167506
Reference: K 6750
EMDN: W0102019002
EMDN description: A1-ANTITRYPSIN (PROTEASE INHIBITOR)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details