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Diagnostic Kit for Myoglobin

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315939
Basic UDI-DI: B-04260163315939
Reference: 07MY5025
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:40

Manufacturer products View details

Diagnostic Kit for Myoglobin (Myo)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315779
Basic UDI-DI: B-04260163315779
Reference: 07MY5025
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:39

Manufacturer products View details

Ischemic Modified Albumin Reagent Kit (ACB Assay)

R1: 1x30ml, R2: 1x10ml, Calibration sample: 2x1mL, Control: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239151
Basic UDI-DI: B-06942202239151
Reference: 3011606
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Ischemic Modified Albumin Reagent Kit (ACB Assay)

R1: 1x30ml, R2: 1x10ml

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239168
Basic UDI-DI: B-06942202239168
Reference: 3011744
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity C-Reactive Protein Kit (Latex Immunoturbidimetric Assay)

R1: 1x60ml, R2: 1x20ml

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238697
Basic UDI-DI: B-06942202238697
Reference: 3012186
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity C-Reactive Protein Kit (Latex Immunoturbidimetric Assay)

R1: 1x60ml, R2: 1x20ml, Calibration sample: 1x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238642
Basic UDI-DI: B-06942202238642
Reference: 3009794
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity C-Reactive Protein Kit (Latex Immunoturbidimetric Assay)

R1: 1x60ml, R2: 1x20ml, Calibration sample: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238659
Basic UDI-DI: B-06942202238659
Reference: 3009796
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity C-Reactive Protein Kit (Latex Immunoturbidimetric Assay)

R1: 1x60ml, R2: 1x20ml, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238666
Basic UDI-DI: B-06942202238666
Reference: 3009798
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

CARDIAC TROPONIN I REAGENT KIT (LATEX ENHANCED IMMUNOTURBIDIMETRIC METHOD)

R1: 1x45ml, R2: 1x15ml, Calibration sample: 5x0.5mL, Control: 2x0.5mL

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239052
Basic UDI-DI: B-06942202239052
Reference: 3009773
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

CARDIAC TROPONIN I REAGENT KIT (LATEX ENHANCED IMMUNOTURBIDIMETRIC METHOD)

R1: 1x45ml, R2: 1x15ml

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239069
Basic UDI-DI: B-06942202239069
Reference: 3014903
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

H-FABP CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548212
Basic UDI-DI: 697015090000259HT
Reference: CMH1105
EMDN: W01021302
EMDN description: HEART-TYPE FATTY ACID BINDING PROTEIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

ST2 (eCLIA)

2×100T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139078457
Basic UDI-DI: B-06978139078457
Reference: ST2 (eCLIA)
EMDN: W01021314
EMDN description: ST2
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 02:25

Manufacturer products Authorised representative products Authorised representative actors View details

ST2 (eCLIA)

100T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139078440
Basic UDI-DI: B-06978139078440
Reference: 0320514801
EMDN: W01021314
EMDN description: ST2
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 02:24

Manufacturer products Authorised representative products Authorised representative actors View details

ST2 (eCLIA)

2×50T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139078433
Basic UDI-DI: B-06978139078433
Reference: 0320514804
EMDN: W01021314
EMDN description: ST2
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 02:24

Manufacturer products Authorised representative products Authorised representative actors View details

ST2 (eCLIA)

50T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139078426
Basic UDI-DI: B-06978139078426
Reference: 0320514803
EMDN: W01021314
EMDN description: ST2
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 02:24

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743137

Type Ⅳ Collagen Chemiluminescence Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743137
Basic UDI-DI: B-06955792743137
Reference: S2155E-200
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:38

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743120

Type Ⅳ Collagen Chemiluminescence Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743120
Basic UDI-DI: B-06955792743120
Reference: S2155E-150
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:38

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743113

Type Ⅳ Collagen Chemiluminescence Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743113
Basic UDI-DI: B-06955792743113
Reference: S2155E-100
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:38

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743106

Type Ⅳ Collagen Chemiluminescence Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743106
Basic UDI-DI: B-06955792743106
Reference: S2155E-75
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:38

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743090

Type Ⅳ Collagen Chemiluminescence Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743090
Basic UDI-DI: B-06955792743090
Reference: S2155E-50
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:38

Manufacturer products Authorised representative products Authorised representative actors View details