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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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02.08.2026 18:51

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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

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

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

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

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

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

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: 06975424223295
Basic UDI-DI: B-06975424223295
Reference: 20 tests/ kit
EMDN: W01021307
EMDN description: HOMOCYSTEINE
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

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: 06975424223226
Basic UDI-DI: B-06975424223226
Reference: 20 tests/ kit.
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 22:38

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 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: 06975424221338
Basic UDI-DI: B-06975424221338
Reference: 20 tests/ kit
EMDN: W01021306
EMDN description: TROPONIN I/T
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

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: 06975424221314
Basic UDI-DI: B-06975424221314
Reference: 20 tests/ kit
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 22:36

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

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: 06975424221284
Basic UDI-DI: B-06975424221284
Reference: 20 tests/ kit
EMDN: W01021306
EMDN description: TROPONIN I/T
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

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

ST2 Test Kit (Dry Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Lansion Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001086
UDI-DI: 06975260988754
Basic UDI-DI: B-06975260988754
Reference: 0032-03
EMDN: W01021314
EMDN description: ST2
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:26

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac troponin I / Myoglobin / Creatine kinase-MB Test Kit (Immunofluorescence Method)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000004533
UDI-DI: 06975132460715
Basic UDI-DI: B-06975132460715
Reference: CTMC-402F-25
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitive Cardiac Troponin-I Test Kit (Immunofluorescence Method)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000004533
UDI-DI: 06975132460517
Basic UDI-DI: B-06975132460517
Reference: CHTI-402F-25
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

100 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Accucise Diagnostics Inc.
Manufacturer SRN: CN-MF-000045017
UDI-DI: 06975090503448
Basic UDI-DI: B-06975090503448
Reference: 1040512000
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 21:56

Manufacturer products Authorised representative products Authorised representative actors View details

100 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Accucise Diagnostics Inc.
Manufacturer SRN: CN-MF-000045017
UDI-DI: 06975090503424
Basic UDI-DI: B-06975090503424
Reference: 1040412000
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 21:56

Manufacturer products Authorised representative products Authorised representative actors View details

100 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Accucise Diagnostics Inc.
Manufacturer SRN: CN-MF-000045017
UDI-DI: 06975090503400
Basic UDI-DI: B-06975090503400
Reference: 1040312000
EMDN: W01021314
EMDN description: ST2
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 21:56

Manufacturer products Authorised representative products Authorised representative actors View details