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406 device results listed.

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cTnI /CK-MB/MYO Panel Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5J04C1XP
Basic UDI-DI: B-5J04C1XP
Reference: 5J04C1-20-EU, 5J04C1-40-EU
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:06

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase-MB Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5J01C1X8
Basic UDI-DI: B-5J01C1X8
Reference: 5J01C1-25-EU, 5J01C1-50-EU
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:06

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5J02C1XD
Basic UDI-DI: B-5J02C1XD
Reference: 5J02C1-25-EU, 5J02C1-50-EU
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:06

Manufacturer products Authorised representative products Authorised representative actors View details

NADAL® Troponin I Test

Troponin I Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-282041N-10XR
Basic UDI-DI: B-nvm-282041N-10XR
Reference: 282041N-10
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:28

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NADAL® Cardiac Combo Test

Cardiac Combo Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-282003SW
Basic UDI-DI: B-nvm-282003SW
Reference: 282003
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:28

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Cardiac Troponin T Test Kit (FIA)

VID60

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID602Z
Basic UDI-DI: B-VID602Z
Reference: VID60-03-011
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Combo (cTnI/CK-MB) Test Kit (FIA)

VID45

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID4535
Basic UDI-DI: B-VID4535
Reference: VID45-03-011
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

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Cardiac Combo (cTnI/CK-MB/MY0) Test Kit (FIA)

VID15

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID152U
Basic UDI-DI: B-VID152U
Reference: VID15-03-011
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

N-terminal Pro-brain Natriuretic Peptide Test Kit (FIA)

VID14

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID142S
Basic UDI-DI: B-VID142S
Reference: VID14-03-011
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

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Heart Fatty Acid Binding Protein Test Kit (FIA)

VID13

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID132Q
Basic UDI-DI: B-VID132Q
Reference: VID13-03-011
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin Test Kit (FIA)

VID12

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID122N
Basic UDI-DI: B-VID122N
Reference: VID12-03-011
EMDN: W0102160702
EMDN description: MYOGLOBIN - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase-MB Test Kit (FIA)

VID10

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID102J
Basic UDI-DI: B-VID102J
Reference: VID10-03-011
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I Test Kit (FIA)

VID09

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID092Z
Basic UDI-DI: B-VID092Z
Reference: VID09-03-011
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin/CK-MB/Troponin I Combo Rapid Test

VCMC-436

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VCMC-436K8
Basic UDI-DI: B-VCMC-436K8
Reference: VCMC-436
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

ST2 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-ST2-D06aFG
Basic UDI-DI: B-ST2-D06aFG
Reference: ST2-D06a
EMDN: W0102160799
EMDN description: CARDIAC MARKERS - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 15.07.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I test kit (6 tests)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: EUROLyser Diagnostica GmbH
Manufacturer SRN: AT-MF-000013746
UDI-DI: D-ST0230D8
Basic UDI-DI: B-ST0230D8
Reference: ST0230
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 10:34

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BGI

50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022027EJ
Basic UDI-DI: B-SAC2022027EJ
Reference: SAC2022027
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

BGI

10 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022026EG
Basic UDI-DI: B-SAC2022026EG
Reference: SAC2022026
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

BGI

5 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022025EE
Basic UDI-DI: B-SAC2022025EE
Reference: SAC2022025
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

BGI

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022006EA
Basic UDI-DI: B-SAC2022006EA
Reference: SAC2022006
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:34

Manufacturer products View details