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115 device results listed.

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Cardiac Troponin I Rapid Test

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104616
Basic UDI-DI: 6970277510000IXT
Reference: CTNI-N402-10
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I Rapid Test Cassette (Serum/Plasma/Whole Blood)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182723422
Basic UDI-DI: B-62230182723422
Reference: D-789 001
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 20.07.2026 04:47

Manufacturer products Authorised representative products Authorised representative actors View details

06935784460402

BF S15

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784460402
Basic UDI-DI: B-06935784460402
Reference: BF-S151
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 19.07.2026 07:57

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI Quantitative Test Kit (Time-Resolved FIA)

FDTRO-402b-DR10, FDTRO-402b-DR10LH, FDTRO-402b-DR10HG, FDTRO-402b-DR, FDTRO-402b-DRLH, FDTRO-402b-DRHG

IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996003889
Basic UDI-DI: 69509960FDTRO-402b-DRDH
Reference: FDTRO-402b-DR10
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Safety summary (SSCP/SSP): CEDR-FDTRO-402b-11.1-OG · Rev. 4.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:49

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

cTnI Quantitative Test Kit (Time-Resolved FIA)

IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996003896
Basic UDI-DI: 69509960FDTRO-402b-DRDH
Reference: FDTRO-402b-DR
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDTRO-402b-11.1-OG · Rev. 4.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:47

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

D-CNMF000014455-BF-S155RV

BF S15

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S155RV
Basic UDI-DI: B-CNMF000014455-BF-S155RV
Reference: BF-S155
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:51

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S154RT

BF S15

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S154RT
Basic UDI-DI: B-CNMF000014455-BF-S154RT
Reference: BF-S154
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:51

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S153RR

BF S15

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S153RR
Basic UDI-DI: B-CNMF000014455-BF-S153RR
Reference: BF-S153
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:51

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S152RP

BF S15

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S152RP
Basic UDI-DI: B-CNMF000014455-BF-S152RP
Reference: BF-S152
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:51

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S075RW

BF-S075

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S075RW
Basic UDI-DI: B-CNMF000014455-BF-S075RW
Reference: BF-S075
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:49

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S074RU

BF S07

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S074RU
Basic UDI-DI: B-CNMF000014455-BF-S074RU
Reference: BF-S074
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:49

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S073RS

BF S07

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S073RS
Basic UDI-DI: B-CNMF000014455-BF-S073RS
Reference: BF-S073
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:49

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S072RQ

BF S07

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S072RQ
Basic UDI-DI: B-CNMF000014455-BF-S072RQ
Reference: BF-S072
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:49

Manufacturer products Authorised representative products Authorised representative actors View details

cTnT Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840311556
Basic UDI-DI: B-69743840311556
Reference: 3050901
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:12

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I(CTNI) Rapid Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CTNI002UCKR
Basic UDI-DI: B-697424646CTNI002UCKR
Reference: CTNI-3012
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I(CTNI) Rapid Test (Whole Blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CTNI001UAKG
Basic UDI-DI: B-697424646CTNI001UAKG
Reference: CTNI-4012
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I FIA Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CTNI001F6W3G
Basic UDI-DI: B-697424646CTNI001F6W3G
Reference: CTNI-3012F
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I FIA Test (Whole blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CTNI000F6T33
Basic UDI-DI: B-697424646CTNI000F6T33
Reference: CTNI-4012F
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Troponin I Test Card

1J02C2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-692196371080288
Basic UDI-DI: B-692196371080288
Reference: 1J02C2
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin - I

1172 001

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041014418
Basic UDI-DI: B-62230041014418
Reference: 1172 001
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:22

Manufacturer products Authorised representative products Authorised representative actors View details