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55 device results listed.

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CRP/ SAA Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD162XL
Basic UDI-DI: B-GKPD162XL
Reference: GKPD162
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI / Myo / CK-MB Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD161XJ
Basic UDI-DI: B-GKPD161XJ
Reference: GKPD161
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI / Myoglobin / CK-MB Triplex Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD134XF
Basic UDI-DI: B-GKPD134XF
Reference: GKPD134
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin/CK-MB/Troponin I Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDCAR-W435a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GDCAR-W435aHGDL
Basic UDI-DI: B-GDCAR-W435aHGDL
Reference: GDCAR-W435a
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin/CK-MB/Troponin I Combo Test Cassette (Serum/Plasma)

GDCAR-335a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GDCAR-335aHGRS
Basic UDI-DI: B-GDCAR-335aHGRS
Reference: GDCAR-335a
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI/CK-MB/MYO Test Kit FIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CMC-D06a8R
Basic UDI-DI: B-CMC-D06a8R
Reference: CMC-D06a
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 05:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-808171QK

cTnI/DD/BNP Rapid Detect

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808171QK
Basic UDI-DI: B-808171QK
Reference: 808171
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-808165QQ

cTnI/MYO/CK-MB Rapid Detect

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808165QQ
Basic UDI-DI: B-808165QQ
Reference: 808165
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

CK-MB/cTnI/Myo Combo Test (FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763471
Basic UDI-DI: B-15065023763471
Reference: TV20009
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:35

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™ cTnI/Myo/CK-MB (FIA)

VMPO35EP

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250469
Basic UDI-DI: B-08683548250469
Reference: VMPO35
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:10

Manufacturer products View details

Cardiac Troponin I/Creatine Kinase-MB/Myoglobin Test Kit (QDs-FICA)

Specification 1: Cardiac Troponin I / Creatine Kinase-MB / Myoglobin Specification 2: Cardiac Troponin I / Myoglobin Each specification is available in the following pack sizes: 1 test/box, 5 tests/box, 10 tests/box, 50 tests/box, and 100 tests/box.

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Chongqing Juce Life Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000053774
UDI-DI: 06977981880157
Basic UDI-DI: B-06977981880157
Reference: CA0901
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Türkiye
Authorised representative: Share info GmbH
Last updated: 07.07.2026 01:37

Manufacturer products Authorised representative products Authorised representative actors View details

N-Terminal pro–B-type Natriuretic Peptide/Cardiac Troponin I/D-dimer Test Kit (QDs-FICA)

1 pcs/box, 5 pcs/box, 10 pcs/box, 50 pcs/box and 100 pcs/box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Chongqing Juce Life Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000053774
UDI-DI: 06977981880102
Basic UDI-DI: B-06977981880102
Reference: CA1101
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Türkiye
Authorised representative: Share info GmbH
Last updated: 07.07.2026 01:37

Manufacturer products Authorised representative products Authorised representative actors View details

06977903346327

25 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneSign Biotech (Xiamen)Co., Ltd.
Manufacturer SRN: CN-MF-000044463
UDI-DI: 06977903346327
Basic UDI-DI: B-06977903346327
Reference: GS120705C25
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Netherlands
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

06977903346310

1 test/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneSign Biotech (Xiamen)Co., Ltd.
Manufacturer SRN: CN-MF-000044463
UDI-DI: 06977903346310
Basic UDI-DI: B-06977903346310
Reference: GS120705C01
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Netherlands
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

06977903342220

25 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneSign Biotech (Xiamen)Co., Ltd.
Manufacturer SRN: CN-MF-000044463
UDI-DI: 06977903342220
Basic UDI-DI: B-06977903342220
Reference: GS110603C25
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

06977903342213

1 test/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneSign Biotech (Xiamen)Co., Ltd.
Manufacturer SRN: CN-MF-000044463
UDI-DI: 06977903342213
Basic UDI-DI: B-06977903342213
Reference: GS110603C01
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

NT-proBNP Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography

25 tests/kit

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698402901
Basic UDI-DI: B-06977698402901
Reference: GKPD057
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB Isoenzyme (CK-MB) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography)

25 tests/kit

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698402840
Basic UDI-DI: B-06977698402840
Reference: GKPD055
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

High-sensitivity Cardiac Troponin I (hs-cTnI) Quantitative Test (Quantum Dot Fluorescence Immunochromatography)

25 tests/kit

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698402789
Basic UDI-DI: B-06977698402789
Reference: GKPD054
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin (Myo) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography)

25 tests/kit

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698402567
Basic UDI-DI: B-06977698402567
Reference: GKPD050
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details