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347 device results listed.

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CK-MB/cTnI Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414702170
Basic UDI-DI: B-06954414702170
Reference: /
EMDN: W01021306
EMDN description: TROPONIN I/T
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

Cardiac Troponin I Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414702002
Basic UDI-DI: B-06954414702002
Reference: /
EMDN: W01021306
EMDN description: TROPONIN I/T
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

TRO-W23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802790
Basic UDI-DI: B-06952804802790
Reference: TRO-W23F3
EMDN: W01021306
EMDN description: TROPONIN I/T
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

06951045810076

50 tests

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSingle use

Manufacturer: Suzhou Sym-Bio Lifescience Co., Ltd.
Manufacturer SRN: CN-MF-000012847
UDI-DI: 06951045810076
Basic UDI-DI: 69510458SF_cTnIFG
Reference: SDX-57015
EMDN: W01021306
EMDN description: TROPONIN I/T
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

In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996004381
Basic UDI-DI: B-06950996004381
Reference: 1CTNTB12
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors View details

In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996004374
Basic UDI-DI: B-06950996004374
Reference: 1CTNTB11
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I (cTnI) Test Kit (Immunofluorescence)

25T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334804482
Basic UDI-DI: B-06950334804482
Reference: 52026004
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Bulgaria
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:40

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Troponin I (CLIA)

Troponin I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145501495
Basic UDI-DI: B-06947145501495
Reference: 130206002M
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

HS-cTnT 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: 06942359511643
Basic UDI-DI: 697015090000260HC
Reference: CMH0610
EMDN: W01021306
EMDN description: TROPONIN I/T
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

High-sensitivity Troponin T CLIA 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: 06942293590865
Basic UDI-DI: 697518250F12008ZU
Reference: F12008
EMDN: W01021306
EMDN description: TROPONIN I/T
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

High-sensitivity Troponin I CLIA 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: 06942293590179
Basic UDI-DI: 697518250F12004ZL
Reference: F12004
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

06941967222613

IVD generalNot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967222613
Basic UDI-DI: B-06941967222613
Reference: 01.09.04.01.EC.01
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 25.06.2026 20:47

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ HS TROPONIN I

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405226
Basic UDI-DI: 69713904307138E
Reference: 010713601
EMDN: W01021306
EMDN description: TROPONIN I/T
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

High Sensitivity Cardiac Troponin I Kit (CLIA)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595751536
Basic UDI-DI: B-06936595751536
Reference: FG1401Y
EMDN: W01021306
EMDN description: TROPONIN I/T
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

Cardiac Troponin I Kit(Latex-Enhanced Immunoturbidimetric Method)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595750430
Basic UDI-DI: B-06936595750430
Reference: MJ423Y
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:54

Manufacturer products Authorised representative products Authorised representative actors View details

Finecare