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EUDAMED Device Search

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

Last updated

01.08.2026 16:25

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349 device results listed.

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cTnI (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4404153J6
Basic UDI-DI: B-IM4404153J6
Reference: IM4404153
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitive Troponin T Chemiluminescent Immunoassay kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403157J7
Basic UDI-DI: B-IM4403157J7
Reference: IM4403157
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitive Troponin I Chemiluminescent Immunoassay kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403156J5
Basic UDI-DI: B-IM4403156J5
Reference: IM4403156
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403153HX
Basic UDI-DI: B-IM4403153HX
Reference: IM4403153
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitive Troponin T Chemiluminescent Immunoassay kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402157HY
Basic UDI-DI: B-IM4402157HY
Reference: IM4402157
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitive Troponin I Chemiluminescent Immunoassay kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402156HW
Basic UDI-DI: B-IM4402156HW
Reference: IM4402156
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402153HQ
Basic UDI-DI: B-IM4402153HQ
Reference: IM4402153
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4401153HH
Basic UDI-DI: B-IM4401153HH
Reference: IM4401153
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:16

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM High‑Sensitivity Troponin I (TnIH)

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414006758
Basic UDI-DI: 0405686900809VV
Reference: 10997841
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI Quantitative Test Kit (Time-Resolved FIA)

FDTRO-402c

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDTRO-402cHGHL
Basic UDI-DI: B-FDTRO-402cHGHL
Reference: FDTRO-402c
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:23

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI Quantitative Test Kit (Time-Resolved FIA)

FDTRO-402c

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDTRO-402cCU
Basic UDI-DI: B-FDTRO-402cCU
Reference: FDTRO-402c
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI Quantitative Test Kit (Time-Resolved FIA)

FDTRO-402b

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDTRO-402bHGHF
Basic UDI-DI: B-FDTRO-402bHGHF
Reference: FDTRO-402b
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI Quantitative Test Kit (Time-Resolved FIA)

FDTRO-402b

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDTRO-402bCS
Basic UDI-DI: B-FDTRO-402bCS
Reference: FDTRO-402b
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

cTnT Quantitative Test Kit (Time-Resolved FIA)

FDTNT-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDTNT-402aHGHD
Basic UDI-DI: B-FDTNT-402aHGHD
Reference: FDTNT-402a
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

cTnT Quantitative Test Kit (Time-Resolved FIA)

FDTNT-

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDTNT-402aCM
Basic UDI-DI: B-FDTNT-402aCM
Reference: FDTNT-402a
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I (cTnI) Test Kit (Immunofluorescence)

50T/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-FA0009ZA
Basic UDI-DI: B-FA0009ZA
Reference: 52027004
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Bulgaria
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DT01827K
Basic UDI-DI: B-DT01827K
Reference: DT0182
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

5 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DT01817H
Basic UDI-DI: B-DT01817H
Reference: DT0181
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DT01287D
Basic UDI-DI: B-DT01287D
Reference: DT0128
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

5 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DT01277B
Basic UDI-DI: B-DT01277B
Reference: DT0127
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details