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PREALBUMIN REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）

R1: 1x50mL, R2: 1x10mL,Calibration sample: 0.8mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202213434
Basic UDI-DI: B-06942202213434
Reference: 3023196
EMDN: W0102010305
EMDN description: PRE-ALBUMIN / TRANSTHYRETIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:47

Manufacturer products Authorised representative products Authorised representative actors View details

PREALBUMIN REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）

R1: 1x50mL, R2: 1x10mL,Calibration sample: 0.8mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202213427
Basic UDI-DI: B-06942202213427
Reference: 3023216
EMDN: W0102010305
EMDN description: PRE-ALBUMIN / TRANSTHYRETIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:47

Manufacturer products Authorised representative products Authorised representative actors View details

MICROALBUMIN REAGENT KIT（IMMUNOTURBIDIMETRIC ASSAY）

R1: 1x40mL, R2: 1x10mL, Calibration sample: 5x0.5mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202213397
Basic UDI-DI: B-06942202213397
Reference: 3023252
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:47

Manufacturer products Authorised representative products Authorised representative actors View details

MICROALBUMIN REAGENT KIT（IMMUNOTURBIDIMETRIC ASSAY）

R1: 1x40mL, R2: 1x10mL, Calibration sample: 5x0.5mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202213380
Basic UDI-DI: B-06942202213380
Reference: 3023245
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:47

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare

Immunoglobulin (IgA/IgG/IgM)Reagent Kit

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009374
Basic UDI-DI: B-06934175009374
Reference: 12600544
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Serum Amyloid A (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858076
Basic UDI-DI: B-06933289858076
Reference: W396P0011
EMDN: W0102019013
EMDN description: BETA-AMYLOID (1-40)
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Serum Amyloid A (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858069
Basic UDI-DI: B-06933289858069
Reference: W396P0010
EMDN: W0102019013
EMDN description: BETA-AMYLOID (1-40)
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Serum Amyloid A (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858052
Basic UDI-DI: B-06933289858052
Reference: W396P0009
EMDN: W0102019013
EMDN description: BETA-AMYLOID (1-40)
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Serum Amyloid A (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858045
Basic UDI-DI: B-06933289858045
Reference: W396P0008
EMDN: W0102019013
EMDN description: BETA-AMYLOID (1-40)
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802384

200 tests

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802384
Basic UDI-DI: B-06930317802384
Reference: DNK-1901-32
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:38

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802377

100 tests

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802377
Basic UDI-DI: B-06930317802377
Reference: DNK-1901-32
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:38

Manufacturer products Authorised representative products Authorised representative actors View details

Urinary Transferrin Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x45mL, R2: 1x15mL,Calibration sample: 1x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794593849
Basic UDI-DI: B-06925794593849
Reference: 3021645
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Urinary Transferrin Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x45mL, R2: 1x15mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794593832
Basic UDI-DI: B-06925794593832
Reference: 3021697
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

TRANSFERRIN REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）

R1: 1x50mL, R2: 1x10mL，Calibration sample: 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794593825
Basic UDI-DI: B-06925794593825
Reference: 3021732
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

LIPOPROTEIN (a) REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）

IVD generalNot specifiedOn the market

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794593740
Basic UDI-DI: B-06925794593740
Reference: 3021727
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Apolipoprotein E Reagent Kit (Immunoturbidimetric Assay)

R1: 1x30mL, R2: 1x10mL，

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794593733
Basic UDI-DI: B-06925794593733
Reference: 3021589
EMDN: W0102010499
EMDN description: LIPOPROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Apolipoprotein E Reagent Kit (Immunoturbidimetric Assay)

R1: 1x30mL, R2: 1x10mL，Calibration sample:1x1mL, Control:1x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794593726
Basic UDI-DI: B-06925794593726
Reference: 3021588
EMDN: W0102010499
EMDN description: LIPOPROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Apolipoprotein C3 Reagent Kit (Immunoturbidimetric Assay)

R1: 1x45mL, R2: 1x15mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794593719
Basic UDI-DI: B-06925794593719
Reference: 3021587
EMDN: W0102010499
EMDN description: LIPOPROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Apolipoprotein C3 Reagent Kit (Immunoturbidimetric Assay)

R1: 1x45mL, R2: 1x15mL,Calibration sample: 1x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794593702
Basic UDI-DI: B-06925794593702
Reference: 3021586
EMDN: W0102010499
EMDN description: LIPOPROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Apolipoprotein C2 Reagent Kit (Immunoturbidimetric Assay)

R1: 1x45mL, R2: 1x15mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794593696
Basic UDI-DI: B-06925794593696
Reference: 3021643
EMDN: W0102010499
EMDN description: LIPOPROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details