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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

AFIAS Microalbumin

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133045374
Basic UDI-DI: 880613300516CB
Reference: SMFP-30
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors 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

Retinol Binding Protein Kit (Particle-enhanced Immunoturbidimetric Assay Method)

105-009269-00、105-002250-00、105-002251-00、105-006182-00、105-004511-00、105-004512-00、105-002304-00、105-002305-00

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904032221
Basic UDI-DI: 69449040004JRBP********HU
Reference: 105-002250-00
EMDN: W0102010306
EMDN description: RETINOL BINDING PROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Transferrin Kit (Immunoturbidimetric Assay Method)

105-006177-00、105-002246-00、105-002247-00、105-006178-00、105-004507-00、105-004508-00、105-002317-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904031484
Basic UDI-DI: 69449040004JTRF********T4
Reference: 105-002246-00
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Microalbumin Kit (Immunoturbidimetric Assay Method)

105-006173-00、105-002242-00、105-002243-00、105-006174-00、105-004503-00、105-004504-00、105-002315-00、105-002316-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904031446
Basic UDI-DI: 69449040004JMALB*******NV
Reference: 105-002242-00
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Immunoglobulin G Kit (Turbidimetry Method)

please see UDI-DI for details

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904025391
Basic UDI-DI: 69449040AB71000023Z
Reference: 105-000883-00
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Microalbumin Kit (Immunoturbidimetry)

please see UDI-DI for details

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053121798
Basic UDI-DI: 69449040AB710000445
Reference: 105-056299-00
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

Immunoglobulin A Kit (Turbidimetry Method)

105-004618-00、105-000881-00、105-001617-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904025377
Basic UDI-DI: 694490400044IGA********AH
Reference: 105-000881-00
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:43

Manufacturer products Authorised representative products Authorised representative actors View details

Complement C3 Kit (Turbidimetry Method)

105-004617-00、105-000878-00、105-001614-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904025346
Basic UDI-DI: 694490400044C3*********3K
Reference: 105-000878-00
EMDN: W0102010203
EMDN description: COMPLEMENT COMPONENT C3/C3C
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:43

Manufacturer products Authorised representative products Authorised representative actors View details