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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

Prealbumin Kit（Turbidimetry Method）

105-000845-00、105-000884-00、105-004607-00、105-001130-00

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: 06944904025018
Basic UDI-DI: 694490400044PA*********TX
Reference: 105-000845-00
EMDN: W0102010305
EMDN description: PRE-ALBUMIN / TRANSTHYRETIN
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

Immunoglobulin M Kit (Turbidimetry Method)

105-000843-00、105-000882-00、105-004606-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904024998
Basic UDI-DI: 694490400044IGM********K5
Reference: 105-000843-00
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
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

Apolipoprotein B Kit (Turbidimetry Method)

105-000838-00、105-000877-00、105-004603-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904024943
Basic UDI-DI: 694490400041ApoB*******B8
Reference: 105-000838-00
EMDN: W0102010403
EMDN description: APOLIPOPROTEIN B
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 C4 Kit (Turbidimetry Method)

105-000840-00、105-000879-00、105-004604-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904024967
Basic UDI-DI: 694490400044C4*********4G
Reference: 105-000840-00
EMDN: W0102010205
EMDN description: COMPLEMENT COMPONENT C4
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

Apolipoprotein A1 Kit (Turbidimetry Method)

105-000837-00、105-000876-00、105-004602-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904024936
Basic UDI-DI: 694490400041ApoA1******EC
Reference: 105-000837-00
EMDN: W0102010401
EMDN description: APOLIPOPROTEIN A I
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

AutoChem PA

AutoChem analyzer

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

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253001226
Basic UDI-DI: 69422530000013N7
Reference: 360101PA0000V
EMDN: W0102010305
EMDN description: PRE-ALBUMIN / TRANSTHYRETIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 19:30

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-IgG4

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912720386
Basic UDI-DI: 692591270248HP
Reference: C86089G
EMDN: W0102010106
EMDN description: IMMUNOGLOBULIN G SUBCLASS REAGENTS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:36

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-IgG3

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912720379
Basic UDI-DI: 692591270262HH
Reference: C86088G
EMDN: W0102010106
EMDN description: IMMUNOGLOBULIN G SUBCLASS REAGENTS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:36

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-IgG2

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912720362
Basic UDI-DI: 692591270261HF
Reference: C86087G
EMDN: W0102010106
EMDN description: IMMUNOGLOBULIN G SUBCLASS REAGENTS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:36

Manufacturer products Authorised representative products Authorised representative actors View details