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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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hs-cTnI Assay Kit (ECLIA)

hs-cTnI Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK014DH
Basic UDI-DI: B-SEK014DH
Reference: SE-K014
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnT Assay Kit (ECLIA)

hs-cTnT Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK013DF
Basic UDI-DI: B-SEK013DF
Reference: SE-K013
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

CA242 Assay Kit (ECLIA)

CA242 Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK009DQ
Basic UDI-DI: B-SEK009DQ
Reference: SE-K009
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

CKMB Assay Kit (ECLIA)

CKMB Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK012DD
Basic UDI-DI: B-SEK012DD
Reference: SE-K012
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

NT-proBNP Assay Kit (ECLIA)

NT-proBNP Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK011DB
Basic UDI-DI: B-SEK011DB
Reference: SE-K011
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

CA50 Assay Kit (ECLIA)

CA50 Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK010D9
Basic UDI-DI: B-SEK010D9
Reference: SE-K010
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

SCC Assay Kit (ECLIA)

SCC Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK008DN
Basic UDI-DI: B-SEK008DN
Reference: SE-K008
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

CA125 Assay Kit (ECLIA)

CA125 Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK007DL
Basic UDI-DI: B-SEK007DL
Reference: SE-K007
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

CYFRA21-1 Assay Kit (ECLIA)

CYFRA21-1 Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK006DJ
Basic UDI-DI: B-SEK006DJ
Reference: SE-K006
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

CA72-4 Assay Kit (ECLIA)

CA72-4 Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK004DE
Basic UDI-DI: B-SEK004DE
Reference: SE-K004
EMDN: W0102030105
EMDN description: CANCER ANTIGEN 72-4
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

CA19-9 Assay Kit (ECLIA)

CA19-9 Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK003DC
Basic UDI-DI: B-SEK003DC
Reference: SE-K003
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

CA15-3 Assay Kit (ECLIA)

CA15-3 Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK002DA
Basic UDI-DI: B-SEK002DA
Reference: SE-K002
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Assay Kit (ECLIA)

AFP Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK001D8
Basic UDI-DI: B-SEK001D8
Reference: SE-K001
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

CEA Assay Kit (ECLIA)

CEA Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SE-K005QU
Basic UDI-DI: B-SE-K005QU
Reference: SE-K005
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

Disposable Rf Plasma Electrodes

Disposable Rf Plasma Electrodes

Class IIbMDDOn the marketActive deviceSingle useSterile

Manufacturer: Beijing ZKSK Technology Co., Ltd
Manufacturer SRN: CN-MF-000010403
UDI-DI: D-RPEFE
Basic UDI-DI: B-RPEFE
Reference: RPE08-40S
EMDN: K020180
EMDN description: SINGLE- AND BIPOLAR DEVICES, SINGLE USE - ACCESSORIES
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene Respiratory Pathogen Panel Pro Detection Kit

Cowingene Respiratory Pathogen Panel Pro Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-RP2602CC
Basic UDI-DI: B-RP2602CC
Reference: RP26021V, RP26021Y, RP26021V-1, RP26021Y-1, RP26022U, RP26022X, RP26022U-1, RP26022X-1
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene Respiratory Pathogen Panel 21 Detection Kit

Cowingene Respiratory Pathogen Panel 21 Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-RP23021VA5
Basic UDI-DI: B-RP23021VA5
Reference: RP23021V
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene Respiratory Pathogen Panel Detection Kit

Cowingene Respiratory Pathogen Panel Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-RP13MA
Basic UDI-DI: B-RP13MA
Reference: RP13021W, RP13022S, RP14021W, RP16023P, RP19023P RP14022U,
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene SARS-CoV-2 & Influenza A/B Detection Kit

Cowingene SARS-CoV-2 & Influenza A/B Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-RP11M6
Basic UDI-DI: B-RP11M6
Reference: RP11021X, RP11022X, RP11023W
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene Influenza A/B and RSV Detection Kit

Cowingene Influenza A/B and RSV Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-RP03M7
Basic UDI-DI: B-RP03M7
Reference: RP03021X, RP03022X, RP03023W
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details