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65 device results listed.

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In vitro Diagnostic Kit for Creatine Kinase-MB (Chemiluminescence Assay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656825
Basic UDI-DI: B-00810173656825
Reference: 1CKMBB02
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

In vitro Diagnostic Kit for Creatine Kinase-MB (Chemiluminescence Assay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656818
Basic UDI-DI: B-00810173656818
Reference: 1CKMBB01
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

D-R036182D

R1: 30ml×2, R2: 15ml×1

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R036182D
Basic UDI-DI: B-R036182D
Reference: R03618
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-R036172B

R1: 40ml×2, R2: 18ml×1

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R036172B
Basic UDI-DI: B-R036172B
Reference: R03617
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-R0361629

R1:60ml×2, R2: 30ml×1

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R0361629
Basic UDI-DI: B-R0361629
Reference: R03616
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-R0361527

R1: 25ml×4, R2: 25ml×1

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R0361527
Basic UDI-DI: B-R0361527
Reference: R03615
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-R0361425

R1：50ml×2，R2：25ml×1

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R0361425
Basic UDI-DI: B-R0361425
Reference: R03614
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-R03612ZW

R1：40ml×2，R2：20ml×1

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R03612ZW
Basic UDI-DI: B-R03612ZW
Reference: R03612
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:52

Manufacturer products Authorised representative products Authorised representative actors View details

SAS-1 CK Vis Kit

201202

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013017530
Basic UDI-DI: B-05056013017530
Reference: 201202
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 17.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

SAS-1 CK Vis Kit

201201

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013009405
Basic UDI-DI: B-05056013009405
Reference: 201201
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 17.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-90AM

Creatine Kinase-MB Isoenzyme (CK-MB) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-90AM
Basic UDI-DI: B-6-90AM
Reference: "REF: USIA00000075M, USIA00000076M"
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-132FD

Creatine Kinase MB Isoenzymes Reagent Kit (Immunosuppressive method)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-132FD
Basic UDI-DI: B-6-132FD
Reference: "REF: U84685040M U84689060M, U84622060M U84685020M"
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

14562185400479

CL AIA-PACK CK-MB ADJUSTER SET

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14562185400479
Basic UDI-DI: B-14562185400479
Reference: 0029234
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:07

Manufacturer products Authorised representative products Authorised representative actors View details

14562185400387

CL AIA-PACK CK-MB TEST CUP

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14562185400387
Basic UDI-DI: B-14562185400387
Reference: 0029134
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:06

Manufacturer products Authorised representative products Authorised representative actors View details

14560189210728

ST AIA-PACK CK-MB

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189210728
Basic UDI-DI: B-14560189210728
Reference: 0025269
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:01

Manufacturer products Authorised representative products Authorised representative actors View details

CK-NAC KİTİ

CK-NAC REAGENT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812532808
Basic UDI-DI: B-08681812532808
Reference: 08V3520
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 18:42

Manufacturer products View details

CK-NAC KİTİ

CK-NAC REAGENT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812532389
Basic UDI-DI: B-08681812532389
Reference: 08V3525
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 18:41

Manufacturer products View details

CK-NAC KİTİ

CK-NAC REAGENT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812526210
Basic UDI-DI: B-08681812526210
Reference: W01010115
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 18:41

Manufacturer products View details

CK-NAC KİTİ

CK-NAC REAGENT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812526203
Basic UDI-DI: B-08681812526203
Reference: 06R55-24
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 18:41

Manufacturer products View details

06979355928205

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: 06979355928205
Basic UDI-DI: B-06979355928205
Reference: 100 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

Manufacturer products Authorised representative products Authorised representative actors View details