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

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163 device results listed.

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INNODX CK-MB STAT CMIA

INNODX CK-MB STAT CMIA

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: 06973600799237
Basic UDI-DI: 697360079026JZ
Reference: KR-CK-MB STAT-0350
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:05

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX CK-MB STAT CMIA

INNODX CK-MB STAT CMIA

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: 06973600799220
Basic UDI-DI: 697360079026JZ
Reference: KR-CK-MB STAT-02200
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:05

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX CK-MB STAT CMIA

INNODX CK-MB STAT CMIA

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: 06973600799213
Basic UDI-DI: 697360079026JZ
Reference: KR-CK-MB STAT-0250
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:05

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX CK-MB STAT CMIA

INNODX CK-MB STAT CMIA

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: 06973600798261
Basic UDI-DI: 697360079026JZ
Reference: KR-CK-MB-03100
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details

30 Tests/kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: 06973224892369
Basic UDI-DI: 69732248900029W
Reference: DC79002
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ CK MB

HOKAPI™ CK MB

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439920
Basic UDI-DI: 69713904307038B
Reference: 010703101
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Isoenzymes (CK-MB) Rapid Test Kit (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664751911
Basic UDI-DI: B-06970664751911
Reference: 25Tests/Kit
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

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

2×50 test/box Calibrator:0.5mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522645994
Basic UDI-DI: B-06970522645994
Reference: CA2201
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 04:46

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class CNot specifiedOn the market

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603185
Basic UDI-DI: 69268026MD71C00001UJ
Reference: MCL01802E
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 29.06.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Fast Test Kit (Immunofluorescence Assay)

CK-MB Fast Test Kit (Immunofluorescence Assay)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792942
Basic UDI-DI: 695441470215H3
Reference: IF5018
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Fast Test Kit (Immunofluorescence Assay)

CK-MB Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414702156
Basic UDI-DI: B-06954414702156
Reference: /
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:25

Manufacturer products Authorised representative products Authorised representative actors View details

CKMB-W23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802806
Basic UDI-DI: B-06952804802806
Reference: CKMB-W23F3
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

SuperFlex Creatine Kinase-MB Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Suzhou Sym-Bio Lifescience Co., Ltd.
Manufacturer SRN: CN-MF-000012847
UDI-DI: 06951045810038
Basic UDI-DI: 69510458SF_CK-MBAD
Reference: SDX-57011
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 28.06.2026 09:35

Manufacturer products Authorised representative products Authorised representative actors View details

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

25T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334804512
Basic UDI-DI: B-06950334804512
Reference: 52026009
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:40

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359511407
Basic UDI-DI: 697015090000037H7
Reference: CMH0310
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:49

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MM Isoenzyme Determination Kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293590773
Basic UDI-DI: 697518250F12101ZK
Reference: F12101
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:30

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Isoenzymes MB CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293590377
Basic UDI-DI: 697518250F12006ZQ
Reference: F12006
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ CK MB

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405165
Basic UDI-DI: 69713904307038B
Reference: 010703601
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:07

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB Kit (Latex-Enhanced Immunoturbidimetric Method)

-

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595752281
Basic UDI-DI: B-06936595752281
Reference: MJ027Y
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB Isozyme Kit (CLIA)

-

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595751543
Basic UDI-DI: B-06936595751543
Reference: FG1404Y
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details