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EUDAMED Device Search

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

Last updated

23.09.2026 04:15

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Device

3540243

Actor

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Certificate

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Active filter:EMDN:W01010115

105 device results listed.

Page 4 / 6

06979355928199

Creatine kinase myocardial isoenzyme (CK-MB) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN
CN-MF-000050949
UDI-DI
06979355928199
Basic UDI-DI
B-06979355928199
Reference
50 tests/kit (including calibration and control)
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Spain
Authorised representative
JOYSUN GROUP S.L.U
Last updated
07.07.2026 02:31
06979355928182

Creatine kinase myocardial isoenzyme (CK-MB) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN
CN-MF-000050949
UDI-DI
06979355928182
Basic UDI-DI
B-06979355928182
Reference
25 tests/kit (including calibration and control)
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Spain
Authorised representative
JOYSUN GROUP S.L.U
Last updated
07.07.2026 02:31
06979355928175

Creatine kinase myocardial isoenzyme (CK-MB) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN
CN-MF-000050949
UDI-DI
06979355928175
Basic UDI-DI
B-06979355928175
Reference
100 tests/kit (including control)
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Spain
Authorised representative
JOYSUN GROUP S.L.U
Last updated
07.07.2026 02:31
06979355928168

Creatine kinase myocardial isoenzyme (CK-MB) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN
CN-MF-000050949
UDI-DI
06979355928168
Basic UDI-DI
B-06979355928168
Reference
50 tests/kit (including control)
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Spain
Authorised representative
JOYSUN GROUP S.L.U
Last updated
07.07.2026 02:31
06979355928151

Creatine kinase myocardial isoenzyme (CK-MB) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN
CN-MF-000050949
UDI-DI
06979355928151
Basic UDI-DI
B-06979355928151
Reference
25 tests/kit (including control)
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Spain
Authorised representative
JOYSUN GROUP S.L.U
Last updated
07.07.2026 02:31
06979355928144

Creatine kinase myocardial isoenzyme (CK-MB) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN
CN-MF-000050949
UDI-DI
06979355928144
Basic UDI-DI
B-06979355928144
Reference
100 tests/kit (including calibration)
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Spain
Authorised representative
JOYSUN GROUP S.L.U
Last updated
07.07.2026 02:31
06979355928137

Creatine kinase myocardial isoenzyme (CKMB) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN
CN-MF-000050949
UDI-DI
06979355928137
Basic UDI-DI
B-06979355928137
Reference
50 tests/kit (including calibration)
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Spain
Authorised representative
JOYSUN GROUP S.L.U
Last updated
07.07.2026 02:31
06979355928120

Creatine kinase myocardial isoenzyme (CKMB) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN
CN-MF-000050949
UDI-DI
06979355928120
Basic UDI-DI
B-06979355928120
Reference
25 tests/kit (including calibration)
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Spain
Authorised representative
JOYSUN GROUP S.L.U
Last updated
07.07.2026 02:31
06979355928113

Creatine kinase myocardial isoenzyme (CKMB) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN
CN-MF-000050949
UDI-DI
06979355928113
Basic UDI-DI
B-06979355928113
Reference
100 tests/kit
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Spain
Authorised representative
JOYSUN GROUP S.L.U
Last updated
07.07.2026 02:31
06979355928106

Creatine kinase myocardial isoenzyme (CKMB) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN
CN-MF-000050949
UDI-DI
06979355928106
Basic UDI-DI
B-06979355928106
Reference
50 tests/kit
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Spain
Authorised representative
JOYSUN GROUP S.L.U
Last updated
07.07.2026 02:31
06979355928090

Creatine kinase myocardial isoenzyme (CKMB) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN
CN-MF-000050949
UDI-DI
06979355928090
Basic UDI-DI
B-06979355928090
Reference
25 tests/kit
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Spain
Authorised representative
JOYSUN GROUP S.L.U
Last updated
07.07.2026 02:31
06975225461742

R1: 80mL×4; R2: 80mL×1

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
Da Te Bioengineering Technology Co., LTD.
Manufacturer SRN
CN-MF-000028832
UDI-DI
06975225461742
Basic UDI-DI
B-06975225461742
Reference
DTSH040211
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 22:13
06975225461735

R1: 60mL×4; R2: 60mL×1

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
Da Te Bioengineering Technology Co., LTD.
Manufacturer SRN
CN-MF-000028832
UDI-DI
06975225461735
Basic UDI-DI
B-06975225461735
Reference
DTSH040210
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 22:13
06975225461728

R1: 60mL×4; R2: 15mL×4

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
Da Te Bioengineering Technology Co., LTD.
Manufacturer SRN
CN-MF-000028832
UDI-DI
06975225461728
Basic UDI-DI
B-06975225461728
Reference
DTSH040201
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 22:12
06975225461711

R1: 60mL×2; R2: 15mL×2

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
Da Te Bioengineering Technology Co., LTD.
Manufacturer SRN
CN-MF-000028832
UDI-DI
06975225461711
Basic UDI-DI
B-06975225461711
Reference
DTSH040209
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 22:12
06975225461698

R1: 60mL×1; R2: 15mL×1

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
Da Te Bioengineering Technology Co., LTD.
Manufacturer SRN
CN-MF-000028832
UDI-DI
06975225461698
Basic UDI-DI
B-06975225461698
Reference
DTSH040207
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 22:12
06975225461681

R1: 40mL×1; R2: 10mL×1

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
Da Te Bioengineering Technology Co., LTD.
Manufacturer SRN
CN-MF-000028832
UDI-DI
06975225461681
Basic UDI-DI
B-06975225461681
Reference
DTSH040206
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 22:12
06975225461704

R1: 40mL×4; R2: 10mL×4

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
Da Te Bioengineering Technology Co., LTD.
Manufacturer SRN
CN-MF-000028832
UDI-DI
06975225461704
Basic UDI-DI
B-06975225461704
Reference
DTSH040208
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 22:12
06975225461674

R1: 20mL×1; R2: 5mL×1

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
Da Te Bioengineering Technology Co., LTD.
Manufacturer SRN
CN-MF-000028832
UDI-DI
06975225461674
Basic UDI-DI
B-06975225461674
Reference
DTSH040205
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 22:12
06974760129902

R1: 2×45 mL, R2: 2×15 mL

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN
CN-MF-000043067
UDI-DI
06974760129902
Basic UDI-DI
B-06974760129902
Reference
R1: 2×45 mL, R2: 2×15 mL
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Austria
Authorised representative
SUNGO Europe B.V.
Last updated
06.07.2026 20:41