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N-terminal pro-brain natriuretic peptide Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792737891
Basic UDI-DI: B-06955792737891
Reference: S2074E-48
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:18

Manufacturer products Authorised representative products Authorised representative actors View details

N-terminal pro-brain natriuretic peptide Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792737884
Basic UDI-DI: B-06955792737884
Reference: S2074E-24
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:18

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792737853
Basic UDI-DI: B-06955792737853
Reference: S2072E-48
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:18

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792737846
Basic UDI-DI: B-06955792737846
Reference: S2072E-24
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:18

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB Isoenzyme Chemiluminescence Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792737051
Basic UDI-DI: B-06955792737051
Reference: S2013E-200
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:15

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB Isoenzyme Chemiluminescence Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792737044
Basic UDI-DI: B-06955792737044
Reference: S2013E-150
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:15

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB Isoenzyme Chemiluminescence Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792737037
Basic UDI-DI: B-06955792737037
Reference: S2013E-100
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:15

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB Isoenzyme Chemiluminescence Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792737020
Basic UDI-DI: B-06955792737020
Reference: S2013E-75
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:15

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB Isoenzyme Chemiluminescence Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792737013
Basic UDI-DI: B-06955792737013
Reference: S2013E-50
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:15

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB Isoenzyme Chemiluminescence Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792737006
Basic UDI-DI: B-06955792737006
Reference: S2013E-25
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:15

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB/cTnI/Myo Fast Test Kit (Immunofluorescence Assay)

CK-MB/cTnI/Myo Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792638
Basic UDI-DI: B-06954414792638
Reference: IF1005、IF2005、 IF3005、IF4005、 IF5005、 IF6005、 IF8005
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 21:54

Manufacturer products Authorised representative products Authorised representative actors View details

Higher-Sensitivity C-Reactive Protein (hs-CRP)Chemiluminescence Quantitative Immunoassay Kit

100 Tests

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN: CN-MF-000020150
UDI-DI: 06954376012546
Basic UDI-DI: B-06954376012546
Reference: 69543760S00080BS
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Isozyme(CK-MB) Chemiluminescence Quantitative Immunoassay Kit

100 Tests

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN: CN-MF-000020150
UDI-DI: 06954376012478
Basic UDI-DI: B-06954376012478
Reference: 69543760F0001566
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 21:51

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitive Troponin-T（hs-cTnT）Assay Kit

100 Tests

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN: CN-MF-000020150
UDI-DI: 06954376005555
Basic UDI-DI: B-06954376005555
Reference: 69543760F000736L
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 21:51

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitive Troponin-I（hs-cTnI）Assay Kit

100 Tests

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN: CN-MF-000020150
UDI-DI: 06954376005548
Basic UDI-DI: B-06954376005548
Reference: 69543760F000726J
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 21:51

Manufacturer products Authorised representative products Authorised representative actors View details

Heart-type Fatty Acid Binding Protein（H-FABP）Assay Kit

100 Tests

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN: CN-MF-000020150
UDI-DI: 06954376005456
Basic UDI-DI: B-06954376005456
Reference: 69543760F000626F
EMDN: W01021302
EMDN description: HEART-TYPE FATTY ACID BINDING PROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin-I（cTnI）Assay Kit

100 Tests

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN: CN-MF-000020150
UDI-DI: 06954376005364
Basic UDI-DI: B-06954376005364
Reference: 69543760F000536E
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

Amino-terminal-brain Natriuretic Peptide Precursor（NT-proBNP）Assay Kit

100 Tests

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN: CN-MF-000020150
UDI-DI: 06954376005340
Basic UDI-DI: B-06954376005340
Reference: 69543760F000516A
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

Soluble Growth Stimulating Expression Gene 2 Protein（ST2）Assay Kit

100 Tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN: CN-MF-000020150
UDI-DI: 06954376005272
Basic UDI-DI: B-06954376005272
Reference: 69543760F000446D
EMDN: W01021314
EMDN description: ST2
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

Heart Fatty Acid-Binding Protein Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x10mL, R2: 1x10mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202261305
Basic UDI-DI: B-06942202261305
Reference: 3012903
EMDN: W01021302
EMDN description: HEART-TYPE FATTY ACID BINDING PROTEIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:29

Manufacturer products Authorised representative products Authorised representative actors View details