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349 device results listed.

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ReLIA

High Sensitivity Cardiac Troponin I (hs-cTnI) Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ReLIA Biotechnologies (Jiangsu), Inc.
Manufacturer SRN: CN-MF-000042042
UDI-DI: 06971354100095
Basic UDI-DI: B-06971354100095
Reference: RF16211-50T
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Slovenia
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

ReLIA

High Sensitivity Cardiac Troponin I (hs-cTnI) Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ReLIA Biotechnologies (Jiangsu), Inc.
Manufacturer SRN: CN-MF-000042042
UDI-DI: 06971354100088
Basic UDI-DI: B-06971354100088
Reference: RF16045-20T
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Slovenia
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo hs-cTnI Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225935863
Basic UDI-DI: B-06971225935863
Reference: KM07018
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo hs-cTnI Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225935818
Basic UDI-DI: B-06971225935818
Reference: KM07060
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go cTnI Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225931292
Basic UDI-DI: B-06971225931292
Reference: FIA13025
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo cTnI Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225931230
Basic UDI-DI: B-06971225931230
Reference: KM01060
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

High-Sensitivity Cardiac Troponin I Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598232033
Basic UDI-DI: B-06942598232033
Reference: FI-SCTI-402
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Ireland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 06.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I(CLIA)

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904065335
Basic UDI-DI: 69449040004L-TnI*******5G
Reference: 105-005676-00
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I Calibrators

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904065458
Basic UDI-DI: 69449040004L-TnI*******5G
Reference: 105-005910-00
EMDN: W01021306
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

PreventID® Cardiac Troponin I

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598013445
Basic UDI-DI: B-04050598013445
Reference: KSTCTI402G5
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:50

Manufacturer products View details

PreventID® Cardiac Troponin I

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598011854
Basic UDI-DI: B-04050598011854
Reference: KSTCTI402G10
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:49

Manufacturer products View details

BIOSYNEX Troponin BSS

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03700531700567
Basic UDI-DI: B-03700531700567
Reference: SW50002
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

D-0230002TK

Troponin I Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: möLab GmbH
Manufacturer SRN: DE-MF-000022941
UDI-DI: D-0230002TK
Basic UDI-DI: B-0230002TK
Reference: 0230002
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: -
Last updated: 05.07.2026 16:16

Manufacturer products View details

cTnI Test Kit (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807166085QR
Basic UDI-DI: B-000012807166085QR
Reference: HWTS-OT102
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ Tn-I Neo

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042977
Basic UDI-DI: 880613300129BY
Reference: CFPC-150
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Cyprus
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI (CLIA)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: DROPHIL BIOTECH (SHENZHEN) COMPANY LIMITED
Manufacturer SRN: CN-MF-000042193
UDI-DI: 06977290930123
Basic UDI-DI: 697729093IC0103F5
Reference: IC01032-048
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 22:24

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ HS TROPONIN I

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405219
Basic UDI-DI: 69713904307138E
Reference: 010713001
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:55

Manufacturer products Authorised representative products Authorised representative actors View details

06926802609811

hs-TnI (CLIA), hs-TnI Control

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

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802609811
Basic UDI-DI: 69268026MD75F00000000012J
Reference: MCL14003E
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 02.07.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603208

IVD Class CNot specifiedOn the marketSingle use

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603208
Basic UDI-DI: 69268026MD71A00001TQ
Reference: MCL01602E
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 02.07.2026 05:34

Manufacturer products Authorised representative products Authorised representative actors View details

VIDAS® High sensitive Troponin I

IVD Class CNot specifiedOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026620929
Basic UDI-DI: 357302BUDI000577U6
Reference: 415386-30
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 03:35

Manufacturer products View details