- Manufacturer
- Genrui Biotech Inc.
- Manufacturer SRN
- CN-MF-000017351
- UDI-DI
- D-FA0012YX
- Basic UDI-DI
- B-FA0012YX
- Reference
- 52027009
- EMDN
- W01021311
- EMDN description
- CREATINE KINASE - MB MASS (IC)
- First on market country
- Romania
- Authorised representative
- Lotus NL B.V.
- Last updated
- 13.07.2026 21:15
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
01.08.2026 16:25
Sync status
Successful
Device
2989392
Actor
47522
Certificate
3174
IVD generalIVDDOn the marketKitProfessional testingReagent
D-ECH01062115M
Creatine Kinase Isoenzyme MB(CK-MB)
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000014618
- UDI-DI
- D-ECH01062115M
- Basic UDI-DI
- B-ECH01062115M
- Reference
- ECH0106211
- EMDN
- W01021311
- EMDN description
- CREATINE KINASE - MB MASS (IC)
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 13.07.2026 18:37
D-ECH01052115E
Creatine Kinase Isoenzyme MB(CK-MB)
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000014618
- UDI-DI
- D-ECH01052115E
- Basic UDI-DI
- B-ECH01052115E
- Reference
- ECH0105211
- EMDN
- W01021311
- EMDN description
- CREATINE KINASE - MB MASS (IC)
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 13.07.2026 18:36
D-ECH01012114J
Creatine Kinase Isoenzyme MB(CK-MB)
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000014618
- UDI-DI
- D-ECH01012114J
- Basic UDI-DI
- B-ECH01012114J
- Reference
- ECH0101211
- EMDN
- W01021311
- EMDN description
- CREATINE KINASE - MB MASS (IC)
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 13.07.2026 18:34
Unicorn-CK-MB
5 Tests/kit
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSelf testing
- Manufacturer
- Shenzhen Drawray Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000008763
- UDI-DI
- D-DT00747F
- Basic UDI-DI
- B-DT00747F
- Reference
- DT0074
- EMDN
- W01021311
- EMDN description
- CREATINE KINASE - MB MASS (IC)
- First on market country
- Spain
- Authorised representative
- Medunion S.L.
- Last updated
- 13.07.2026 17:15
Unicorn-CK-MB
20 Tests/kit
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Shenzhen Drawray Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000008763
- UDI-DI
- D-DT00106M
- Basic UDI-DI
- B-DT00106M
- Reference
- DT0010
- EMDN
- W01021311
- EMDN description
- CREATINE KINASE - MB MASS (IC)
- First on market country
- Spain
- Authorised representative
- Medunion S.L.
- Last updated
- 13.07.2026 17:14
iStar-CK-MB
30 Tests
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Shenzhen Drawray Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000008763
- UDI-DI
- D-DC79002FL
- Basic UDI-DI
- B-DC79002FL
- Reference
- DC79002
- EMDN
- W01021311
- EMDN description
- CREATINE KINASE - MB MASS (IC)
- First on market country
- Netherlands
- Authorised representative
- Lotus NL B.V.
- Last updated
- 13.07.2026 16:17
iStar-CK-MB Ⅱ
2×50 Tests/kit
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Shenzhen Drawray Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000008763
- UDI-DI
- D-DC76136FM
- Basic UDI-DI
- B-DC76136FM
- Reference
- DC76136
- EMDN
- W01021311
- EMDN description
- CREATINE KINASE - MB MASS (IC)
- First on market country
- Spain
- Authorised representative
- Medunion S.L.
- Last updated
- 13.07.2026 16:06
iStar-CK-MB Ⅱ
25 Tests/kit
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Shenzhen Drawray Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000008763
- UDI-DI
- D-DC76134FH
- Basic UDI-DI
- B-DC76134FH
- Reference
- DC76134
- EMDN
- W01021311
- EMDN description
- CREATINE KINASE - MB MASS (IC)
- First on market country
- Spain
- Authorised representative
- Medunion S.L.
- Last updated
- 13.07.2026 16:06
iStar-CK-MB Ⅱ
2×25 Tests/kit
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Shenzhen Drawray Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000008763
- UDI-DI
- D-DC76135FK
- Basic UDI-DI
- B-DC76135FK
- Reference
- DC76135
- EMDN
- W01021311
- EMDN description
- CREATINE KINASE - MB MASS (IC)
- First on market country
- Spain
- Authorised representative
- Medunion S.L.
- Last updated
- 13.07.2026 16:06
iStar-CK-MB Ⅱ
30 Tests/kit 25 Tests/kit
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Shenzhen Drawray Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000008763
- UDI-DI
- D-DC76100EY
- Basic UDI-DI
- B-DC76100EY
- Reference
- DC76100
- EMDN
- W01021311
- EMDN description
- CREATINE KINASE - MB MASS (IC)
- First on market country
- Spain
- Authorised representative
- Medunion S.L.
- Last updated
- 13.07.2026 16:04
CK-MB Creatine Kinase MB (CLIA)
CK-MB Creatine Kinase MB (CLIA)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- Manufacturer SRN
- CN-MF-000028093
- UDI-DI
- D-CKMB706-AERT
- Basic UDI-DI
- B-CKMB706-AERT
- Reference
- CKMB706-AE10Y, CKMB706-AE10N, CKMB706-AE20Y, CKMB706-AE20N
- EMDN
- W01021311
- EMDN description
- CREATINE KINASE - MB MASS (IC)
- First on market country
- Spain
- Authorised representative
- Medunion S.L.
- Last updated
- 13.07.2026 05:06
Creatine Kinase-MB assay (CLIA)
Creatine Kinase-MB assay (CLIA)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Xiamen Boson Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000001096
- UDI-DI
- D-7J01EF
- Basic UDI-DI
- B-7J01EF
- Reference
- 7J01V1-B-EU, 7J01U1-B-EU, 7J01P1-B-EU
- EMDN
- W01021311
- EMDN description
- CREATINE KINASE - MB MASS (IC)
- First on market country
- Germany
- Authorised representative
- MedPath GmbH
- Last updated
- 12.07.2026 09:28
Creatine Kinase Isoenzyme MB (CK-MB) /Cardiac Troponin I (cTnI)/ Myoglobin (MYO) Test Kit (QDs Immunofluorescence Method)
AFS-1000, AFS-2000A, AFS-3000B, iSIA01, iSIA02, iSIA03, iSIA01A, iSIA01B, IFC-100.
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
- Manufacturer
- Chongqing iSIA BIO-Technology Co., Ltd.
- Manufacturer SRN
- CN-MF-000003364
- UDI-DI
- 26974969792345
- Basic UDI-DI
- B-26974969792345
- Reference
- 14W
- EMDN
- W01021311
- EMDN description
- CREATINE KINASE - MB MASS (IC)
- First on market country
- Italy
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 11.07.2026 16:16
Creatine Kinase-MB Isoenzyme Test Kit (CLIA)
Creatine Kinase-MB Isoenzyme Test Kit (CLIA)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Healgen Life Science LLC
- Manufacturer SRN
- US-MF-000043017
- UDI-DI
- 20850076346236
- Basic UDI-DI
- B-20850076346236
- Reference
- CDCRP-401a
- EMDN
- W01021311
- EMDN description
- CREATINE KINASE - MB MASS (IC)
- First on market country
- Ireland
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 11.07.2026 15:03
IVD Class CNot specifiedOn the market
- Manufacturer
- SHENZHEN YHLO BIOTECH CO., LTD.
- Manufacturer SRN
- CN-MF-000001137
- UDI-DI
- 06925912723028
- Basic UDI-DI
- 692591270042GZ
- Reference
- C89242-S
- EMDN
- W01021311
- EMDN description
- CREATINE KINASE - MB MASS (IC)
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 11.07.2026 13:48
CK-MB Rapid Quantitative Test
20 boxes/carton
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Coei Biotech Co.Ltd.
- Manufacturer SRN
- CN-MF-000049509
- UDI-DI
- 16977565580647
- Basic UDI-DI
- B-16977565580647
- Reference
- 0642
- EMDN
- W01021311
- EMDN description
- CREATINE KINASE - MB MASS (IC)
- First on market country
- France
- Authorised representative
- Medunion S.L.
- Last updated
- 11.07.2026 10:09
Creatine Kinase-MB Isoenzyme Test Kit (CLIA)
Creatine Kinase-MB Isoenzyme Test Kit (CLIA)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Healgen Life Science LLC
- Manufacturer SRN
- US-MF-000043017
- UDI-DI
- 10850076346239
- Basic UDI-DI
- B-10850076346239
- Reference
- CDCRP-401a
- EMDN
- W01021311
- EMDN description
- CREATINE KINASE - MB MASS (IC)
- First on market country
- Ireland
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 11.07.2026 04:37
06979878281351
Creatine Kinase Isoenzyme -MB Test (Fluorescence Immunoassay)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Huzhou Jierunxin Biotechnology Co., LTD
- Manufacturer SRN
- CN-MF-000047637
- UDI-DI
- 06979878281351
- Basic UDI-DI
- B-06979878281351
- Reference
- 1001029
- EMDN
- W01021311
- EMDN description
- CREATINE KINASE - MB MASS (IC)
- First on market country
- Austria
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA
- Last updated
- 07.07.2026 02:51
Creatine Kinase MB Isoenzyme (CK-MB) Test Kit (Quantum Dots Fluorescence Immunochromatography)
A4402CC
IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingReagentSingle use
- Manufacturer
- Nanjing Vazyme Medical Technology Co.,Ltd.
- Manufacturer SRN
- CN-MF-000031032
- UDI-DI
- 06979469760968
- Basic UDI-DI
- B-06979469760968
- Reference
- A4402CC
- EMDN
- W01021311
- EMDN description
- CREATINE KINASE - MB MASS (IC)
- First on market country
- Spain
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA
- Last updated
- 07.07.2026 02:42