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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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458 device results listed.

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IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232256017
Basic UDI-DI: B-06976232256017
Reference: CA06-10-113P1
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:40

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Rapid Test

GCCK

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202763279
Basic UDI-DI: B-06976202763279
Reference: GCCK-402
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin Rapid Test

GCMYO

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202763224
Basic UDI-DI: B-06976202763224
Reference: GCMYO-402
EMDN: W0102160702
EMDN description: MYOGLOBIN - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Combo Rapid Test

GCMCT

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202763132
Basic UDI-DI: B-06976202763132
Reference: GCMCT-432
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin/CK-MB/Troponin I Combo Rapid Test

GCMCT

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762951
Basic UDI-DI: B-06976202762951
Reference: GCMCT-432
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin T (cTnT) Rapid Test

GCCTNT

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762425
Basic UDI-DI: B-06976202762425
Reference: GCCTNT-402
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I (cTnI) Test

GCCTNI

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762418
Basic UDI-DI: B-06976202762418
Reference: GCCTNI-A402
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I Test

GCCTNI

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762050
Basic UDI-DI: B-06976202762050
Reference: GCCTNI-A402
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

BNP Test Kit (Dry Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Lansion Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001086
UDI-DI: 06975260988419
Basic UDI-DI: B-06975260988419
Reference: 0050-03
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:24

Manufacturer products Authorised representative products Authorised representative actors View details

N-terminal pro-B-type natriuretic Peptide Test Kit (Immunofluorescence Method)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000004533
UDI-DI: 06975132460616
Basic UDI-DI: B-06975132460616
Reference: CNTBNP-402F-25
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for cTnI (Immunochromatographic assay)

20tests/kit

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068491180
Basic UDI-DI: B-06975068491180
Reference: CP003.B2
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 21:32

Manufacturer products Authorised representative products Authorised representative actors View details

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

20tests/kit

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068491142
Basic UDI-DI: B-06975068491142
Reference: CP007.B2
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 21:32

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Cardiac troponin I（Immunochromatographic assay）

25Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490565
Basic UDI-DI: B-06975068490565
Reference: CP003.B1
EMDN: W0102160703
EMDN description: TROPONIN I/T - 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 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

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