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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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22.07.2026 17:10

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Lung Cancer Associated Gene Methylation Detection Kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630174
Basic UDI-DI: B-06976043630174
Reference: 017
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Human 10-Gene Mutation Detection Kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630143
Basic UDI-DI: B-06976043630143
Reference: 014
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

CEA Assay Kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630136
Basic UDI-DI: B-06976043630136
Reference: 013
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

SM Antibody Detection Kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630129
Basic UDI-DI: B-06976043630129
Reference: 012
EMDN: W0102100111
EMDN description: SM
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

CCP IgG Rapid Kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630112
Basic UDI-DI: B-06976043630112
Reference: 011
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

dsDNA IgG Rapid Kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630105
Basic UDI-DI: B-06976043630105
Reference: 010
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

B3

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630099
Basic UDI-DI: B-06976043630099
Reference: 009
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

B2

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630082
Basic UDI-DI: B-06976043630082
Reference: 008
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

B1

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630075
Basic UDI-DI: B-06976043630075
Reference: 007
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

A3

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630068
Basic UDI-DI: B-06976043630068
Reference: 006
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

A2

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630051
Basic UDI-DI: B-06976043630051
Reference: 005
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

A1

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630044
Basic UDI-DI: B-06976043630044
Reference: 004
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

EA-IgG, Zta-IgG, and EBNA-IgA Test Kit (Colloidal Gold Immunochromatographic Assay)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Genebiohealth Co., Ltd.
Manufacturer SRN: CN-MF-000046424
UDI-DI: 06975977120102
Basic UDI-DI: B-06975977120102
Reference: NPC010-100
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:16

Manufacturer products Authorised representative products Authorised representative actors View details

EA-IgG, Zta-IgG, and EBNA-IgA Test Kit (Colloidal Gold Immunochromatographic Assay)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Genebiohealth Co., Ltd.
Manufacturer SRN: CN-MF-000046424
UDI-DI: 06975977120096
Basic UDI-DI: B-06975977120096
Reference: NPC010-50
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:16

Manufacturer products Authorised representative products Authorised representative actors View details

EA-IgG, Zta-IgG, and EBNA-IgA Test Kit (Colloidal Gold Immunochromatographic Assay)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Genebiohealth Co., Ltd.
Manufacturer SRN: CN-MF-000046424
UDI-DI: 06975977120089
Basic UDI-DI: B-06975977120089
Reference: NPC010-10
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:16

Manufacturer products Authorised representative products Authorised representative actors View details

Reprimo and CABIN1 DNA Methylation Detection Kit (Fluorescence PCR Assay)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Genebiohealth Co., Ltd.
Manufacturer SRN: CN-MF-000046424
UDI-DI: 06975977120072
Basic UDI-DI: B-06975977120072
Reference: GC010-24
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:16

Manufacturer products Authorised representative products Authorised representative actors View details

Reprimo and CABIN1 DNA Methylation Detection Kit (Fluorescence PCR Assay)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Genebiohealth Co., Ltd.
Manufacturer SRN: CN-MF-000046424
UDI-DI: 06975977120065
Basic UDI-DI: B-06975977120065
Reference: GC010-48
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:16

Manufacturer products Authorised representative products Authorised representative actors View details

miR-92a Assay Kit (RT-PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Genebiohealth Co., Ltd.
Manufacturer SRN: CN-MF-000046424
UDI-DI: 06975977120010
Basic UDI-DI: B-06975977120010
Reference: CRC010
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:16

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/Influenza B/RSV Nucleic Acid Test Card

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Guangzhou Pluslife Biotech Co., Ltd
Manufacturer SRN: CN-MF-000025784
UDI-DI: 06975327120196
Basic UDI-DI: B-06975327120196
Reference: RM1010402-10
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 06.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

Pluslife SARS-CoV-2/Influenza A/Influenza B Card

SARS-CoV-2/Influenza A/Influenza B Nucleic Acid Test Card

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Guangzhou Pluslife Biotech Co., Ltd
Manufacturer SRN: CN-MF-000025784
UDI-DI: 06975327120189
Basic UDI-DI: B-06975327120189
Reference: RM1010302-10
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 06.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details