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

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202 device results listed.

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Cardiac Markers Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4291509LB
Basic UDI-DI: B-IM4291509LB
Reference: IM4291509
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:13

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Markers Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4291508L9
Basic UDI-DI: B-IM4291508L9
Reference: IM4291508
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:13

Manufacturer products Authorised representative products Authorised representative actors View details

FDTRO-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDTRO-PN20HGXH
Basic UDI-DI: B-FDTRO-PN20HGXH
Reference: FDTRO-PN20
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
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

FDTRO-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDTRO-PN20LG
Basic UDI-DI: B-FDTRO-PN20LG
Reference: FDTRO-PN20
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
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

FDTNT-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDTNT-PN20LD
Basic UDI-DI: B-FDTNT-PN20LD
Reference: FDTNT-PN20
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
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

FDTNT-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDTNT-PN20HGXL
Basic UDI-DI: B-FDTNT-PN20HGXL
Reference: FDTNT-PN20
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
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

FDMYO-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDMYO-PN20L2
Basic UDI-DI: B-FDMYO-PN20L2
Reference: FDMYO-PN20
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
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

FDMYO-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDMYO-PN20HGW7
Basic UDI-DI: B-FDMYO-PN20HGW7
Reference: FDMYO-PN20
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
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

FDCKM-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDCKM-PN20HG9V
Basic UDI-DI: B-FDCKM-PN20HG9V
Reference: FDCKM-PN20
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

FDCKM-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDCKM-PN205U
Basic UDI-DI: B-FDCKM-PN205U
Reference: FDCKM-PN20
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

NT-proBNP Control

FDBNP-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDBNP-PN20HGCW
Basic UDI-DI: B-FDBNP-PN20HGCW
Reference: FDBNP-PN20
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

NT-proBNP Control

FDBNP-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDBNP-PN2083
Basic UDI-DI: B-FDBNP-PN2083
Reference: FDBNP-PN20
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

FDBNA-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDBNA-PN20ZV
Basic UDI-DI: B-FDBNA-PN20ZV
Reference: FDBNA-PN20
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

FDBNA-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDBNA-PN20HG3Z
Basic UDI-DI: B-FDBNA-PN20HG3Z
Reference: FDBNA-PN20
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

CK & CK-MB Controlv

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01952118H
Basic UDI-DI: B-ECH01952118H
Reference: ECH0195211
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

CK & CK-MB Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01942118A
Basic UDI-DI: B-ECH01942118A
Reference: ECH0194211
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

CK & CK-MB Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01922117U
Basic UDI-DI: B-ECH01922117U
Reference: ECH0192211
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:40

Manufacturer products Authorised representative products Authorised representative actors View details

CK & CK-MB Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01912117M
Basic UDI-DI: B-ECH01912117M
Reference: ECH0191211
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:39

Manufacturer products Authorised representative products Authorised representative actors View details

Seronorm® Cardiac Acute Liq L-1A

Seronorm® Cardiac Acute Liq L-1A

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: SERO AS
Manufacturer SRN: NO-MF-000012954
UDI-DI: 27090041920594
Basic UDI-DI: B-27090041920594
Reference: 211005
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Norway
Authorised representative: -
Last updated: 11.07.2026 16:16

Manufacturer products View details

Pathonorm® Cardiac Acute Liq L-3

Pathonorm® Cardiac Acute Liq L-3

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: SERO AS
Manufacturer SRN: NO-MF-000012954
UDI-DI: 17090041921914
Basic UDI-DI: B-17090041921914
Reference: 216205
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Norway
Authorised representative: -
Last updated: 11.07.2026 10:12

Manufacturer products View details