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cTnI Rapid Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490510
Basic UDI-DI: B-06975679490510
Reference: cTnI
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Rapid Quantitative Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490428
Basic UDI-DI: B-06975679490428
Reference: CK-MB
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

NT-proBNP Rapid Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490411
Basic UDI-DI: B-06975679490411
Reference: NT-proBNP
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI STAT (eCLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139071731
Basic UDI-DI: 69703416803205080JK
Reference: 0320513402
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI STAT (eCLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139071748
Basic UDI-DI: 69703416803205080JK
Reference: 0320513403
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI STAT (eCLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139071755
Basic UDI-DI: 69703416803205080JK
Reference: 0320513404
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

Homocysteine Assay Kit (Fluorescence Immunoassay)

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424225565
Basic UDI-DI: B-06975424225565
Reference: DL233601C
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Assay Kit（Fluorescence Immunoassay）

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424225473
Basic UDI-DI: B-06975424225473
Reference: DL202301C
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I/Creatine Kinase MB/Myoglobin Assay Kit(Fluorescence Immunoassay)

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424225435
Basic UDI-DI: B-06975424225435
Reference: DL191201C
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin T Assay Kit (Fluorescence Immunoassay)

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424225428
Basic UDI-DI: B-06975424225428
Reference: DL191101C
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I Assay Kit (Fluorescence Immunoassay)

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424225411
Basic UDI-DI: B-06975424225411
Reference: DL191001C
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

N-terminal pro-brain nitric peptide Assay Kit (Fluorescence Immunoassay)

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424225404
Basic UDI-DI: B-06975424225404
Reference: DL190801C
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

C- reactive Protein Assay Kit (Fluorescence Immunoassay)

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424225374
Basic UDI-DI: B-06975424225374
Reference: DL190101C
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

06975424223851

50tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424223851
Basic UDI-DI: B-06975424223851
Reference: DL233606
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

06975424223738

50tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424223738
Basic UDI-DI: B-06975424223738
Reference: DL202306
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

06975424223684

50tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424223684
Basic UDI-DI: B-06975424223684
Reference: DL191206
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

06975424223653

50tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424223653
Basic UDI-DI: B-06975424223653
Reference: DL190805
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

06975424223677

50tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424223677
Basic UDI-DI: B-06975424223677
Reference: DL191105
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

06975424223660

50tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424223660
Basic UDI-DI: B-06975424223660
Reference: DL191005
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

06975424223585

50tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424223585
Basic UDI-DI: B-06975424223585
Reference: DL190107
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details