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63 device results listed.

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cTnI/Myoglobin/CK-MB FIA

CfMCT4312

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-CfMCT431XV
Basic UDI-DI: B-CfMCT431XV
Reference: CfMCT4312
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin/CK-MB/Troponin I Rapid Test Cassette (WB/S/P)

CMCT4312

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-CMCT431VF
Basic UDI-DI: B-CMCT431VF
Reference: CMCT4312
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Markers Combo Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-CMC-475K3
Basic UDI-DI: B-ACO-CMC-475K3
Reference: ACO-CMC-475
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

06941571818097

R180-116

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571818097
Basic UDI-DI: B-06941571818097
Reference: R180-116
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin/CK-MB/Troponin I Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983188715
Basic UDI-DI: B-06936983188715
Reference: CMA-435
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Cardiac Panel Test Card

1J04C2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963711434
Basic UDI-DI: B-06921963711434
Reference: 1J04C2
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

See Now

See Now cardiac panel (cTnI, CKMB, MYO)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: S.C. CAMP MEDICA DISTRIBUTION SRL
Manufacturer SRN: RO-MF-000002110
UDI-DI: 05944759012240
Basic UDI-DI: B-05944759012240
Reference: SN 6.X.3
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Romania
Authorised representative: -
Last updated: 03.08.2026 01:44

Manufacturer products View details

DyonCardiac 3 in 1

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: DYONMED SA
Manufacturer SRN: GR-MF-000033588
UDI-DI: 05200251201040
Basic UDI-DI: B-05200251201040
Reference: DNAT708
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:48

Manufacturer products View details

06935784460204

BF S05

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784460204
Basic UDI-DI: B-06935784460204
Reference: BF-S051
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - 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/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA)

FDCAR-T402a-DR10, FDCAR-T402a-DR10LH, FDCAR-T402a-DR10HG, FDCAR-T402a-DR, FDCAR-T402a-DRLH, FDCAR-T402a-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: 06950996003865
Basic UDI-DI: 69509960FDCAR-T402a-DRQ4
Reference: FDCAR-T402a-DR10
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Safety summary (SSCP/SSP): CEDR-FDCAR-T402a-11-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/CK-MB/Myo 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: 06950996003872
Basic UDI-DI: 69509960FDCAR-T402a-DRQ4
Reference: FDCAR-T402a-DR
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDCAR-T402a-11-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

cTnI/CK-MB/Myo 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: 06950996037464
Basic UDI-DI: 69509960FDCAR-T402a-DRQ4
Reference: FDCAR-T402a-DR10LH
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDCAR-T402a-11-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

cTnI/CK-MB/Myo 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: 06950996061698
Basic UDI-DI: 69509960FDCAR-T402a-DRQ4
Reference: FDCAR-T402a-DRLH
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDCAR-T402a-11-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-S055RQ

BF S05

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-S055RQ
Basic UDI-DI: B-CNMF000014455-BF-S055RQ
Reference: BF-S055
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Ireland
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-S054RN

BF S05

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-S054RN
Basic UDI-DI: B-CNMF000014455-BF-S054RN
Reference: BF-S054
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - 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-S053RL

BF S05

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-S053RL
Basic UDI-DI: B-CNMF000014455-BF-S053RL
Reference: BF-S053
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - 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-S052RJ

BF S05

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-S052RJ
Basic UDI-DI: B-CNMF000014455-BF-S052RJ
Reference: BF-S052
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - 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

Myoglobin/CK‐MB/Troponin I Rapid Combo 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: 69743840311860
Basic UDI-DI: B-69743840311860
Reference: 3051301
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - 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 Markers Combo Rapid Test (Serum/Plasma) （CTNI/CKMB/MYO）

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CMC002ESRA
Basic UDI-DI: B-697424646CMC002ESRA
Reference: CMC-3032a
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:03

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Markers Combo Rapid Test (Whole Blood/Serum/Plasma) （CTNI/CKMB/MYO）

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CMC001EQQZ
Basic UDI-DI: B-697424646CMC001EQQZ
Reference: CMC-4032a
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:03

Manufacturer products Authorised representative products Authorised representative actors View details