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115 device results listed.

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Lepzi cTnI Test

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Lepzi Diagnostika Ltd.
Manufacturer SRN: BG-MF-000051504
UDI-DI: 03800502152026
Basic UDI-DI: B-03800502152026
Reference: LD_BG003
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Bulgaria
Authorised representative: -
Last updated: 05.07.2026 22:36

Manufacturer products View details

Troponin I (cTnI) Rapid Test Kit (QDs Immunofluorescence Method)

AFS-1000, AFS-2000A, AFS-3000B, iSIA01, iSIA02, iSIA03, iSIA01A, iSIA01B, IFC-100

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

Manufacturer: Chongqing iSIA BIO-Technology Co., Ltd.
Manufacturer SRN: CN-MF-000003364
UDI-DI: 26974969792246
Basic UDI-DI: 69749697901002DR
Reference: 02W
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:50

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI Test Kit（colloidal gold immunochromatographic assay）

1 test/bag

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangmei Tianhong Biotech (Beijing) Co., Ltd.
Manufacturer SRN: CN-MF-000014412
UDI-DI: 06970877687007
Basic UDI-DI: B-06970877687007
Reference: 0701
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® Troponin I Cassette (Whole Blood/Serum/Plasma)

Cassette

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581430463
Basic UDI-DI: B-06970581430463
Reference: ABT-CT-B59
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:42

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I Rapid Test

TRO-W23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804816711
Basic UDI-DI: B-06952804816711
Reference: TRO-W23
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

High-sensitive Cardiac Troponin I Chemiluminescence Immunoassay Test Kit

G104A08

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804814953
Basic UDI-DI: B-06952804814953
Reference: G104A08
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I Rapid Test