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167 device results listed.

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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB Isoenzyme (CK-MB) Test Kit (Quantum Dots Fluorescence Immunochromatography)

A4404CC

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06979469760951
Basic UDI-DI: B-06979469760951
Reference: A4404CC
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

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB Isoenzyme (CK-MB) Test Kit (Quantum Dots Fluorescence Immunochromatography)

A4403CV

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06979469760944
Basic UDI-DI: B-06979469760944
Reference: A4403CV
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

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB Isoenzyme (CK-MB) Test Kit (Quantum Dots Fluorescence Immunochromatography)

A4403CC

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06979469760937
Basic UDI-DI: B-06979469760937
Reference: A4403CC
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

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB Isoenzyme (CK-MB) Test Kit (Quantum Dots Fluorescence Immunochromatography)

A4402CL

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06979469760920
Basic UDI-DI: B-06979469760920
Reference: A4402CL
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

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase-MB (CK-MB) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000046524
UDI-DI: 06978198482226
Basic UDI-DI: B-06978198482226
Reference: 2222
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB (CK-MB) Assay Kits (Lateral Flow Immunoassay)

25 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139075807
Basic UDI-DI: B-06978139075807
Reference: 745009
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Rapid Quantitative Test

25 servings/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Coei Biotech Co.Ltd.
Manufacturer SRN: CN-MF-000049509
UDI-DI: 06977565580640
Basic UDI-DI: B-06977565580640
Reference: 0642
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine kinase MB(CK-MB) Determination Kit(Chemiluminescence Immunoassay)

10 Tests/Kit or 20 Tests/Kit

IVD generalIVDDOn the marketReagentSingle use

Manufacturer: Shenzhen Channel Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000053778
UDI-DI: 06976968300749
Basic UDI-DI: B-06976968300749
Reference: CR026EU01
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:11

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Rapid Test Device (Whole Blood/Serum/Plasma)

J020501D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753474990
Basic UDI-DI: B-06976753474990
Reference: J020501D
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB (CK-MB) Assay Reagent Kit (CMIA)

C2KL005

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753472019
Basic UDI-DI: B-06976753472019
Reference: C2KL005
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB (CK-MB) Assay Kits (Lateral Flow Immunoassay)

100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984067827
Basic UDI-DI: B-06975984067827
Reference: 0320300903
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB (CK-MB) Assay Kits (Lateral Flow Immunoassay)

50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984067810
Basic UDI-DI: B-06975984067810
Reference: 0320300902
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB (CK-MB) Assay Kits (Lateral Flow Immunoassay)

10 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984067803
Basic UDI-DI: B-06975984067803
Reference: 0320300901
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB STAT (CK-MB STAT) eCLIA

2×100T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063294
Basic UDI-DI: B-06975984063294
Reference: 691044
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:18

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB STAT (CK-MB STAT) eCLIA

2×50T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063287
Basic UDI-DI: B-06975984063287
Reference: 691042
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:18

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB (Electrochemiluminescence Immunoassay)

2×50T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063096
Basic UDI-DI: B-06975984063096
Reference: 691040
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

06975090503424

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