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01.08.2026 01:12

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49 device results listed.

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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

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: 06975424221420
Basic UDI-DI: B-06975424221420
Reference: 20 tests/ kit
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:36

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: 06975424221291
Basic UDI-DI: B-06975424221291
Reference: 20 tests/ kit
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

06975358885316

Male factor infertility detection kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biofast Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000027220
UDI-DI: 06975358885316
Basic UDI-DI: B-06975358885316
Reference: 04110008
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:29

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay S100-β (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070762575
Basic UDI-DI: B-06975070762575
Reference: 18315101
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Ireland
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin/CK-MB/Troponin I Assay Kit (Fluorescence Immunochromatography)

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06974986813784
Basic UDI-DI: B-06974986813784
Reference: 100 tests/kit
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:21

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin/CK-MB/Troponin I Assay Kit (Fluorescence Immunochromatography)

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06974986813777
Basic UDI-DI: B-06974986813777
Reference: 50 tests/kit
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:21

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin/CK-MB/Troponin I Assay Kit (Fluorescence Immunochromatography)

25 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06974986813760
Basic UDI-DI: B-06974986813760
Reference: 25 tests/kit
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:21

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin/CK-MB/Troponin I Assay Kit (Fluorescence Immunochromatography)

10 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06974986813753
Basic UDI-DI: B-06974986813753
Reference: 10 tests/kit
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:21

Manufacturer products Authorised representative products Authorised representative actors View details

C Reactive Protein/Serum Amyloid A (CRP/SAA) Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854621114
Basic UDI-DI: B-06974854621114
Reference: P2206125
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI/CK-MB/Myo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854621077
Basic UDI-DI: B-06974854621077
Reference: P22057
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:54

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I (cTnI) Detection Kit(Fluorescence Immunoassay)

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674891704
Basic UDI-DI: B-06974674891704
Reference: 18-02-0117
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:12

Manufacturer products Authorised representative products Authorised representative actors View details

One Step CK MB/Myoglobin/ Troponin I Combo Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303025
Basic UDI-DI: B-06974566303025
Reference: CMC-432
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Denmark
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

hs cTnI /CK-MB/MyoRapid Test Kit (Quantum Dot Fluorescence Immunoassay)

XJ008

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473300575
Basic UDI-DI: B-06974473300575
Reference: XJ008
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB/cTnI/Myo Rapid Test Kit

A02002002

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861684143
Basic UDI-DI: B-06973861684143
Reference: A02002002
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 17:43

Manufacturer products Authorised representative products Authorised representative actors View details

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

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangdong Wesail Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008828
UDI-DI: 06973841001007
Basic UDI-DI: B-06973841001007
Reference: BA0130
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details

Homoarginin ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598008687
Basic UDI-DI: B-04050598008687
Reference: K 7859
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:47

Manufacturer products View details

ADMA ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598001213
Basic UDI-DI: B-04050598001213
Reference: K 7828
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:40

Manufacturer products View details

Thrombomodulin Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465235890
Basic UDI-DI: 697846523ProteinC12RJ
Reference: 2×100 test
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

Thrombomodulin Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465235883
Basic UDI-DI: 697846523ProteinC12RJ
Reference: 100 tests
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 30.06.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details