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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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D-1947C

Lipoprotein (a) Test Kit (Latex Immunoturbidimetric Method)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-1947C
Basic UDI-DI: B-1947C
Reference: /
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 14:16

Manufacturer products Authorised representative products Authorised representative actors View details

D-1937A

Apolipoprotein E Test Kit (Latex Immunoturbidimetric Method)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-1937A
Basic UDI-DI: B-1937A
Reference: /
EMDN: W0102010404
EMDN description: APOLIPOPROTEIN E SUB-TYPING
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 14:16

Manufacturer products Authorised representative products Authorised representative actors View details

D-19176

Transferrin Kit (Immunoturbidimetric Method)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-19176
Basic UDI-DI: B-19176
Reference: /
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 14:16

Manufacturer products Authorised representative products Authorised representative actors View details

D-19074

D-Dimer Assay Kit (Latex Immunoturbidimetric Method)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-19074
Basic UDI-DI: B-19074
Reference: /
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 14:16

Manufacturer products Authorised representative products Authorised representative actors View details

D-1897K

Sialic Acid Assay Kit (Enzymatic Method)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-1897K
Basic UDI-DI: B-1897K
Reference: /
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 14:16

Manufacturer products Authorised representative products Authorised representative actors View details

19358706000113

AlloSeq HCT Software

IVD generalIVDDOn the marketProfessional testing

Manufacturer: CareDx Pty Ltd
Manufacturer SRN: AU-MF-000046711
UDI-DI: 19358706000113
Basic UDI-DI: B-19358706000113
Reference: ASHCTS2
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 14:12

Manufacturer products Authorised representative products Authorised representative actors View details

19358706000106

AlloSeq HCT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: CareDx Pty Ltd
Manufacturer SRN: AU-MF-000046711
UDI-DI: 19358706000106
Basic UDI-DI: B-19358706000106
Reference: ASHCT.1(96)-IVD
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 14:12

Manufacturer products Authorised representative products Authorised representative actors View details

19358706000090

AlloSeq cfDNA Software

IVD generalIVDDOn the marketProfessional testing

Manufacturer: CareDx Pty Ltd
Manufacturer SRN: AU-MF-000046711
UDI-DI: 19358706000090
Basic UDI-DI: B-19358706000090
Reference: ASCFS1.0
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 14:12

Manufacturer products Authorised representative products Authorised representative actors View details

19358706000083

AlloSeq cfDNA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: CareDx Pty Ltd
Manufacturer SRN: AU-MF-000046711
UDI-DI: 19358706000083
Basic UDI-DI: B-19358706000083
Reference: ASCF.1(24)-IVD
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 14:12

Manufacturer products Authorised representative products Authorised representative actors View details

19358706000076

AlloSeq Assign

IVD generalIVDDOn the marketProfessional testing

Manufacturer: CareDx Pty Ltd
Manufacturer SRN: AU-MF-000046711
UDI-DI: 19358706000076
Basic UDI-DI: B-19358706000076
Reference: ASA1.0
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

19358706000069

AlloSeq Tx 9(96) Set B