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407 device results listed.

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Diagnostic Kit for Cardiac troponin I/creatine kinase isoenzyme MB/myoglobin（Immunochromatographic assay）

25Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490558
Basic UDI-DI: B-06975068490558
Reference: CP014.B1
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 21:31

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for N-terminal pro-B-type natriuretic peptide（Immunochromatographic assay）

25Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490497
Basic UDI-DI: B-06975068490497
Reference: CP007.B1
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 21:31

Manufacturer products Authorised representative products Authorised representative actors View details

POCBio Troponin I Rapid Test

LATC01-C50

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nexlab Co., Ltd.
Manufacturer SRN: CN-MF-000047094
UDI-DI: 06974912093884
Basic UDI-DI: B-06974912093884
Reference: LATC01-C50
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 21:02

Manufacturer products Authorised representative products Authorised representative actors View details

POCBio Troponin I Rapid Test

LATC01-C25

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nexlab Co., Ltd.
Manufacturer SRN: CN-MF-000047094
UDI-DI: 06974912093877
Basic UDI-DI: B-06974912093877
Reference: LATC01-C25
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 21:02

Manufacturer products Authorised representative products Authorised representative actors View details

mLabs® Cardiac Panel 3

M101-091011

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703166353
Basic UDI-DI: B-06974703166353
Reference: M101-091011
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

mLabs® NT-proBNP

M101-091005

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703166339
Basic UDI-DI: B-06974703166339
Reference: M101-091005
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

mLabs® BNP

M101-091004

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703166322
Basic UDI-DI: B-06974703166322
Reference: M101-091004
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

mLabs® Troponin I

M101-091003

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703166315
Basic UDI-DI: B-06974703166315
Reference: M101-091003
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303049
Basic UDI-DI: B-06974566303049
Reference: CMY-402
EMDN: W0102160702
EMDN description: MYOGLOBIN - RT & POC
First on market country: Denmark
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Cardiac Troponin I (cTnI) (Time-resolved Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000501
Basic UDI-DI: B-06974521000501
Reference: SUPF013025
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Rapid Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000013536
UDI-DI: 06974464591500
Basic UDI-DI: B-06974464591500
Reference: 5164C4X025
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin (Myo) Rapid Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000013536
UDI-DI: 06974464591494
Basic UDI-DI: B-06974464591494
Reference: 5174C4X025
EMDN: W0102160702
EMDN description: MYOGLOBIN - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

BNP Test Kit (FIA)

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangdong Wesail Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008828
UDI-DI: 06973841001168
Basic UDI-DI: B-06973841001168
Reference: BA0480
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details

Heart Type Fatty Acid Binding Protein Test Kit (Immunofluorescence)

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangdong Wesail Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008828
UDI-DI: 06973841000987
Basic UDI-DI: B-06973841000987
Reference: BA0200
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin Test Kit (Immunofluorescence)

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangdong Wesail Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008828
UDI-DI: 06973841000963
Basic UDI-DI: B-06973841000963
Reference: BA0120
EMDN: W0102160702
EMDN description: MYOGLOBIN - RT & POC
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Isoenzyme-MB Test Kit (Immunofluorescence)

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangdong Wesail Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008828
UDI-DI: 06973841000932
Basic UDI-DI: B-06973841000932
Reference: BA0110
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity Cardiac Troponin I Test Kit (Immunofluorescence)

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangdong Wesail Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008828
UDI-DI: 06973841000857
Basic UDI-DI: B-06973841000857
Reference: BA0010
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

N-terminal pro-Brain Natriuretic Peptide Test Kit (Immunofluorescence)

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangdong Wesail Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008828
UDI-DI: 06973841000840
Basic UDI-DI: B-06973841000840
Reference: BA0020
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

06972719605491

Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719605491
Basic UDI-DI: B-06972719605491
Reference: 100tests/kit
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:50

Manufacturer products Authorised representative products Authorised representative actors View details

06972719605484

Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719605484
Basic UDI-DI: B-06972719605484
Reference: 50tests/kit
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:50

Manufacturer products Authorised representative products Authorised representative actors View details