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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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BRCAaccuTest PLUS

NGB112V-024

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: NGeneBio Co., Ltd.
Manufacturer SRN: KR-MF-000042887
UDI-DI: 08809539870106
Basic UDI-DI: B-08809539870106
Reference: NGB112V-024
EMDN: W01060203
EMDN description: BRCA 1+2
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.07.2026 15:14

Manufacturer products Authorised representative products Authorised representative actors View details

BRCAaccuTest PLUS

NGB112V-012

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: NGeneBio Co., Ltd.
Manufacturer SRN: KR-MF-000042887
UDI-DI: 08809539870083
Basic UDI-DI: B-08809539870083
Reference: NGB112V-012
EMDN: W01060203
EMDN description: BRCA 1+2
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.07.2026 15:14

Manufacturer products Authorised representative products Authorised representative actors View details

PNAClamp™ KRAS Mutation Detection Kit (Ver.4)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: HLB PANAGENE
Manufacturer SRN: KR-MF-000042004
UDI-DI: 08809378688948
Basic UDI-DI: B-08809378688948
Reference: PNAC-1006
EMDN: W01060202
EMDN description: K-RAS
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:46

Manufacturer products Authorised representative products Authorised representative actors View details

MAF (16q23)/D16Z3

KBI-00116

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973349358
Basic UDI-DI: B-08717973349358
Reference: KBI-00116
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

SE 17 (D17Z1) - XL

KBI-XL020

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973349266
Basic UDI-DI: B-08717973349266
Reference: KBI-XL020
EMDN: W01060213
EMDN description: HER-2/NEU (BREAST CANCER)
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

ESWR1 (22q12) Proximal - XL

KBI-XL019

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973349259
Basic UDI-DI: B-08717973349259
Reference: KBI-XL019
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

SS18 (18q11) Distal - XL

KBI-XL018

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973349242
Basic UDI-DI: B-08717973349242
Reference: KBI-XL018
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

FUS (16p11) Proximal - XL

KBI-XL017

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973349235
Basic UDI-DI: B-08717973349235
Reference: KBI-XL017
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

FOXO1 (13q14) Distal - XL

KBI-XL016

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973349228
Basic UDI-DI: B-08717973349228
Reference: KBI-XL016
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

DDIT3 (12q13) Proximal - XL

KBI-XL015

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973349211
Basic UDI-DI: B-08717973349211
Reference: KBI-XL015
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

MDM2 (12q15) - XL

KBI-XL014

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973349204
Basic UDI-DI: B-08717973349204
Reference: KBI-XL014
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

CCND1 (11q13) Proximal - XL

KBI-XL013

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973349198
Basic UDI-DI: B-08717973349198
Reference: KBI-XL013
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

BCL2 (18q21) Distal - XL

KBI-XL008

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973349082
Basic UDI-DI: B-08717973349082
Reference: KBI-XL008
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

BCL6 (3q27) Proximal - XL

KBI-XL009

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973349099
Basic UDI-DI: B-08717973349099
Reference: KBI-XL009
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

MYC (8q24) Distal - XL

KBI-XL006

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973349068
Basic UDI-DI: B-08717973349068
Reference: KBI-XL006
EMDN: W01060205
EMDN description: C-MYC
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

IGH (14q32) Distal - XL

KBI-XL007

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973349075
Basic UDI-DI: B-08717973349075
Reference: KBI-XL007
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

MET (7q31) - XL

KBI-XL003

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973349037
Basic UDI-DI: B-08717973349037
Reference: KBI-XL003
EMDN: W01060205
EMDN description: C-MYC
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

ROS1 (6q22) Proximal XL

KBI-XL002

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973349020
Basic UDI-DI: B-08717973349020
Reference: KBI-XL002
EMDN: W01060205
EMDN description: C-MYC
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

ALK (2p23) Proximal - XL

KBI-XL001

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973349013
Basic UDI-DI: B-08717973349013
Reference: KBI-XL001
EMDN: W01060205
EMDN description: C-MYC
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

ROS1 (6q22) Break

KBI-10752

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973348948
Basic UDI-DI: B-08717973348948
Reference: KBI-10752
EMDN: W01060205
EMDN description: C-MYC
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details