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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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02.08.2026 10:00

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Active filter:EMDN:W01021607

406 device results listed.

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Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDTRO-402b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGGDTRO-402bZH
Basic UDI-DI: B-OGGDTRO-402bZH
Reference: GDTRO-402b
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

NT-proBNP 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-NT-proBNP-D06a9N
Basic UDI-DI: B-NT-proBNP-D06a9N
Reference: NT-proBNP-D06a
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors View details

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-MYO-D06aRX
Basic UDI-DI: B-MYO-D06aRX
Reference: MYO-D06a
EMDN: W0102160702
EMDN description: MYOGLOBIN - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 05:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-010NY

Myoglobin (Myo) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-010NY
Basic UDI-DI: B-K90411-010NY
Reference: /
EMDN: W0102160702
EMDN description: MYOGLOBIN - RT & POC
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-009PF

Cardiac Troponin I (cTnI) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-009PF
Basic UDI-DI: B-K90411-009PF
Reference: /
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-003P3

N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-003P3
Basic UDI-DI: B-K90411-003P3
Reference: /
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:36

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-IVD83-02-50tDY
Basic UDI-DI: B-IVD83-02-50tDY
Reference: IVD83-02-50t
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-IVD83-02-30tDN
Basic UDI-DI: B-IVD83-02-30tDN
Reference: IVD83-02-30t
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

IVD generalNot specifiedOn the marketSingle useSterile

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-IVD83-02-25tDY
Basic UDI-DI: B-IVD83-02-25tDY
Reference: IVD83-02-25t
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

IVD generalNot specifiedOn the marketSingle useSterile

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-IVD83-02-20tDH
Basic UDI-DI: B-IVD83-02-20tDH
Reference: IVD83-02-20t
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-IVD83-02-10tDC
Basic UDI-DI: B-IVD83-02-10tDC
Reference: IVD83-02-10t
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

IVD generalNot specifiedOn the marketSingle useSterile

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-IVD83-02-100tAQ
Basic UDI-DI: B-IVD83-02-100tAQ
Reference: IVD83-02-100t
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4106203H3

Myoglobin (MYO) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4106203H3
Basic UDI-DI: B-IM4106203H3
Reference: IM4106203
EMDN: W0102160702
EMDN description: MYOGLOBIN - RT & POC
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4106202GZ

Cardiac Troponin I (cTnI) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4106202GZ
Basic UDI-DI: B-IM4106202GZ
Reference: IM4106202
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4106201GX

Creatine Kinase Isoenzyme MB (CK-MB) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4106201GX
Basic UDI-DI: B-IM4106201GX
Reference: IM4106201
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4105203GU

Myoglobin (MYO) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4105203GU
Basic UDI-DI: B-IM4105203GU
Reference: IM4105203
EMDN: W0102160702
EMDN description: MYOGLOBIN - RT & POC
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4105202GS

Cardiac Troponin I (cTnI) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4105202GS
Basic UDI-DI: B-IM4105202GS
Reference: IM4105202
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4105201GQ

Creatine Kinase Isoenzyme MB (CK-MB) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4105201GQ
Basic UDI-DI: B-IM4105201GQ
Reference: IM4105201
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4104203GM

Myoglobin (MYO) Assay Kit by Fluorescence Immunochromatographic Metho

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4104203GM
Basic UDI-DI: B-IM4104203GM
Reference: IM4104203
EMDN: W0102160702
EMDN description: MYOGLOBIN - RT & POC
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4104202GK

Cardiac Troponin I (cTnI) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4104202GK
Basic UDI-DI: B-IM4104202GK
Reference: IM4104202
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details