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α1-antitrypsin Reagent Kit (Immunoturbidimetric Assay)

R1: 1x15mL, R2: 1x5mL, Calibration sample: 1x0.5mL, Control: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794591982
Basic UDI-DI: B-06925794591982
Reference: 3021706
EMDN: W0102019002
EMDN description: A1-ANTITRYPSIN (PROTEASE INHIBITOR)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:45

Manufacturer products Authorised representative products Authorised representative actors View details

α1-acid Glycoprotein Reagent Kit (Immunoturbidimetric Assay)

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

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794592019
Basic UDI-DI: B-06925794592019
Reference: 3021707
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:45

Manufacturer products Authorised representative products Authorised representative actors View details

α1-acid Glycoprotein Reagent Kit (Immunoturbidimetric Assay)

R1: 1x40mL, R2: 1x10mL,

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794592002
Basic UDI-DI: B-06925794592002
Reference: 3021522
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Detection Kit (Latex Immunoturbidimetric Assay)

R1: 1x25mL, R2: 1x25mL,Diluent：1x55mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794591951
Basic UDI-DI: B-06925794591951
Reference: 3021572
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Detection Kit (Latex Immunoturbidimetric Assay)

R1: 1x25mL, R2: 1x25mL,Diluent：1x55mL, Calibrator: 6x0.5mL, Control:Low value:1x0.5mL High value: 1x0.5mL

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794591944
Basic UDI-DI: B-06925794591944
Reference: 3021633
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details

MICROALBUMIN REAGENT KIT（IMMUNOTURBIDIMETRIC ASSAY）

R1: 1L, R2: 250mL，Calibration sample:5x10mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794581334
Basic UDI-DI: B-06925794581334
Reference: 3019349
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details

Adiponectin Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x30mL, R2: 1x10mL,Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577061
Basic UDI-DI: B-06925794577061
Reference: 3019848
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors View details

Adiponectin Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x30mL, R2: 1x10mL, Calibration sample: 1x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577054
Basic UDI-DI: B-06925794577054
Reference: 3019806
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors View details

Adiponectin Reagent Kit (Latex Immunoturbidimetric Assay)

R1：1x30mL, R2：1x10mL,

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577047
Basic UDI-DI: B-06925794577047
Reference: 3019813
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors View details

Adiponectin Reagent Kit (Latex Immunoturbidimetric Assay)

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

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577030
Basic UDI-DI: B-06925794577030
Reference: 3019775
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors View details

Adiponectin Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x30mL, R2: 1x10mL, Calibration sample: 1x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577023
Basic UDI-DI: B-06925794577023
Reference: 3019849
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors View details

Adiponectin Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x30mL, R2: 1x10mL,

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577016
Basic UDI-DI: B-06925794577016
Reference: 3019847
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors View details

β2-Microglobulin Detection Kit (Chemiluminescence Immunoassay)

1×100 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794518255
Basic UDI-DI: B-06925794518255
Reference: 3010690
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:34

Manufacturer products Authorised representative products Authorised representative actors View details

β2-Microglobulin Detection Kit (Chemiluminescence Immunoassay)

1×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794518248
Basic UDI-DI: B-06925794518248
Reference: 3010670
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:34

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Cystatin C Test Card

1M15C2

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963716996
Basic UDI-DI: B-06921963716996
Reference: 1M15C2
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:59

Manufacturer products Authorised representative products Authorised representative actors View details

BIOHIT Calprotectin

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587022604
Basic UDI-DI: B-06419587022604
Reference: 602260
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

Manufacturer products View details

Gastrin-17 Advanced

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587010359
Basic UDI-DI: B-06419587010359
Reference: 601035
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

Manufacturer products View details

Pepsinogen II

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587010205
Basic UDI-DI: B-06419587010205
Reference: 601020.02
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

Manufacturer products View details

Pepsinogen I

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587010106
Basic UDI-DI: B-06419587010106
Reference: 601010.01
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

Manufacturer products View details

AURYX 90 SAA Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514601325
Basic UDI-DI: B-05907514601325
Reference: I20-R0004
EMDN: W0102019012
EMDN description: AMYLOID BETA-DERIVED DIFFUSIBLE LIGAND (BETA-AMYLOID OLIGOMER)
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 00:56

Manufacturer products View details