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559 device results listed.

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Fibrin (Fibrinogen) Degradation Products Detection Kit(Latex Immunoturbidimetric Assay)

R1: 1x25mL, R2: 1x25mL, Fibrin (Fibrinogen) Degradation Products Diluent：1x55mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202237812
Basic UDI-DI: B-06942202237812
Reference: 3015059
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

Fibrin (Fibrinogen) Degradation Products Detection Kit(Latex Immunoturbidimetric Assay)

R1: 1x25mL, R2: 1x25mL, Fibrin (Fibrinogen) Degradation Products Diluent：1x55mL, Fibrin (Fibrinogen) Degradation Products Calibrator: 6x0.5mL, Fibrin (Fibrinogen) Degradation Products Control: Low 5x1mL，High 5x1mL

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202237829
Basic UDI-DI: B-06942202237829
Reference: 3015111
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 22:56

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: 06942202200571
Basic UDI-DI: B-06942202200571
Reference: 3018469
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 22:55

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: 06942202200588
Basic UDI-DI: B-06942202200588
Reference: 3018456
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Urinary Immunoglobulin G 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: 06942202200922
Basic UDI-DI: B-06942202200922
Reference: 3018582
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Urinary Immunoglobulin G 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: 06942202200915
Basic UDI-DI: B-06942202200915
Reference: 3018570
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

MICROALBUMIN REAGENT KIT（IMMUNOTURBIDIMETRIC ASSAY）

R1: 1x40mL, R2: 1x10mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202240928
Basic UDI-DI: B-06942202240928
Reference: 3012541
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:57

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: 06942202239601
Basic UDI-DI: B-06942202239601
Reference: 3014909
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:57

Manufacturer products Authorised representative products Authorised representative actors View details

β2-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）

R1: 1x40mL, R2: 1x10mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238192
Basic UDI-DI: B-06942202238192
Reference: 3012512
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:56

Manufacturer products Authorised representative products Authorised representative actors View details

β2-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）

R1: 1x40mL, R2: 1x10mL, Calibration sample: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238185
Basic UDI-DI: B-06942202238185
Reference: 3014886
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:56

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Albumin Reagent Kit (Ketamine Oxidase Assay)

R1：1x20mL, R2：1x5mL, R3：1x30mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238444
Basic UDI-DI: B-06942202238444
Reference: 3012984
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:55

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Albumin Reagent Kit (Ketamine Oxidase Assay)

R1：1x20mL, R2：1x5mL, R3：1x30mL,Glycated albumin calibration sample：1×1mL, Albumin calibration sample：1×1mL, Glycated albumin control: 2x1mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238451
Basic UDI-DI: B-06942202238451
Reference: 3012826
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:55

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 LH

IVDR_67_LLB_DUB-C_B_REAG_Luteinizing Hormone

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961705
Basic UDI-DI: 0405686901434VF
Reference: 10381212
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 06.08.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 FSH

IVDR_67_LLB_DUB-C_B_REAG_KIT_follicle stimulating hor

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961507
Basic UDI-DI: 0405686901382VM
Reference: 10381201
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 06.08.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

β2-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）

Calibration sample: 1×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202261589
Basic UDI-DI: B-06942202261589
Reference: 232021502013
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 14:32

Manufacturer products Authorised representative products Authorised representative actors View details

FD Darm check professionell

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: FROST Diagnostika GmbH
Manufacturer SRN: DE-MF-000034832
UDI-DI: 04262550791012
Basic UDI-DI: B-04262550791012
Reference: FD-N-DCH-20
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:47

Manufacturer products View details

04260154637217

Beta-Defensin 2 ELISA (960 tests)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ImmuChrom GmbH
Manufacturer SRN: DE-MF-000033427
UDI-DI: 04260154637217
Basic UDI-DI: B-04260154637217
Reference: IC7210
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:37

Manufacturer products View details

04260154637200

Beta-Defensin 2 ELISA (96 tests)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ImmuChrom GmbH
Manufacturer SRN: DE-MF-000033427
UDI-DI: 04260154637200
Basic UDI-DI: B-04260154637200
Reference: IC7200
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:37

Manufacturer products View details

04260154637101

Zonulin ELISA testkit (96tests)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ImmuChrom GmbH
Manufacturer SRN: DE-MF-000033427
UDI-DI: 04260154637101
Basic UDI-DI: B-04260154637101
Reference: IC7100
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:37

Manufacturer products View details

04260154636517

EDN ELISA (96 tests)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: ImmuChrom GmbH
Manufacturer SRN: DE-MF-000033427
UDI-DI: 04260154636517
Basic UDI-DI: B-04260154636517
Reference: IC6510
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:37

Manufacturer products View details