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04560189211063

ST AIA-PACK cTnI 3rd-Gen SAMPLE DILUTING SOLUTION

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189211063
Basic UDI-DI: B-04560189211063
Reference: 0025515
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

04560189211056

ST AIA-PACK cTnI 3rd-Gen CALIBRATOR SET

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189211056
Basic UDI-DI: B-04560189211056
Reference: 0025315
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:42

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: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656849
Basic UDI-DI: B-00810173656849
Reference: 1CTNTB02
EMDN: W01021306
EMDN description: TROPONIN I/T
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 High sensitivity Troponin T (Chemiluminescence Assay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656832
Basic UDI-DI: B-00810173656832
Reference: 1CTNTB01
EMDN: W01021306
EMDN description: TROPONIN I/T
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

High Sensitive Troponin T test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700408997
Basic UDI-DI: 697029753465M2
Reference: HGCL75
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin-I test (Up-converting Phosphor Technology)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403275
Basic UDI-DI: 697029753309LK
Reference: HGUPT05
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

High sensitive Cardiac Troponin-I test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403077
Basic UDI-DI: 697029753045L8
Reference: HGCL01
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:07

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: 06942359548311
Basic UDI-DI: 697015090000260HC
Reference: CMH0605
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

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: 06942359548298
Basic UDI-DI: 697015090000260HC
Reference: CMH0603
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI 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: 06942359547390
Basic UDI-DI: 697015090000036H5
Reference: CMH0203
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I(CLIA)

105-005659-00、105-005676-00、105-005910-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904065212
Basic UDI-DI: 69449040004L-TnI*******5G
Reference: 105-005659-00
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603192

TnI (CLIA)

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

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603192
Basic UDI-DI: 69268026MD71A00001TQ
Reference: MCL01601E
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:41

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-hs-cTnI

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912719922
Basic UDI-DI: 692591270266HR
Reference: C86304
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:35

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Troponin-I

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715481
Basic UDI-DI: 692591270043H3
Reference: C89243-L
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

VIDAS® High sensitive Troponin I

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026433147
Basic UDI-DI: 357302BUDI000577U6
Reference: 415386
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

Manufacturer products View details

High Sensitive Cardiac Troponin I (hs-cTnI) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334825159
Basic UDI-DI: B-06950334825159
Reference: 52026262
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 28.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin T（cTnT）Diagnostic Kit ( Immunochromatographic Assay)

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348761165
Basic UDI-DI: B-06971348761165
Reference: MF-84-20
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I (cTnI) Diagnostic Kit(Immunochromatographic Assay)

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762407
Basic UDI-DI: B-06971348762407
Reference: MF-31-25
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:53

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I (cTnI) Diagnostic Kit(Immunochromatographic Assay)

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760014
Basic UDI-DI: B-06971348760014
Reference: MF-31-20
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:51

Manufacturer products Authorised representative products Authorised representative actors View details

D-R148142Z

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R148142Z
Basic UDI-DI: B-R148142Z
Reference: R14814
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details