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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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03.08.2026 02:01

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682 device results listed.

Page 12 / 35

HEMEaccuTest DNA

NGB121V-048

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: NGeneBio Co., Ltd.
Manufacturer SRN: KR-MF-000042887
UDI-DI: 08809539870137
Basic UDI-DI: B-08809539870137
Reference: NGB121V-048
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.07.2026 15:14

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

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

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

EWSR1 (22q12) Break

KBI-10750

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973348832
Basic UDI-DI: B-08717973348832
Reference: KBI-10750
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) Break (tissue)

KBI-10745

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973348184
Basic UDI-DI: B-08717973348184
Reference: KBI-10745
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) Break

KBI-10716

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973342915
Basic UDI-DI: B-08717973342915
Reference: KBI-10716
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) Break

KBI-10715

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973342908
Basic UDI-DI: B-08717973342908
Reference: KBI-10715
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 Break

KBI-10714

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973342892
Basic UDI-DI: B-08717973342892
Reference: KBI-10714
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) Break

KBI-10713

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973342885
Basic UDI-DI: B-08717973342885
Reference: KBI-10713
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) Break (tissue)

KBI-10730

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973342854
Basic UDI-DI: B-08717973342854
Reference: KBI-10730
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 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

MDM2 (12q15)/SE 12

KBI-10717

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973342823
Basic UDI-DI: B-08717973342823
Reference: KBI-10717
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 18:46

Manufacturer products Authorised representative products Authorised representative actors View details