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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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21.09.2026 21:15

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976 device results listed.

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05745000468836

48T

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468836
Basic UDI-DI: B-05745000468836
Reference: MFG030014
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 02.08.2026 22:56

Manufacturer products View details

05745000468508

Sentis-PanCancer, Sentis-PanCancer-CL

IVD generalIVDDOn the marketProfessional testing

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468508
Basic UDI-DI: B-05745000468508
Reference: MFG020007
EMDN: W01060202
EMDN description: K-RAS
First on market country: Denmark
Authorised representative: -
Last updated: 02.08.2026 22:56

Manufacturer products View details

05745000468492

24T

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468492
Basic UDI-DI: B-05745000468492
Reference: MFG030041
EMDN: W01060202
EMDN description: K-RAS
First on market country: Denmark
Authorised representative: -
Last updated: 02.08.2026 22:56

Manufacturer products View details

05745000468034

32 tests/kit, 64tests/kit

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468034
Basic UDI-DI: B-05745000468034
Reference: MFG030013, MFG030019
EMDN: W01060203
EMDN description: BRCA 1+2
First on market country: Denmark
Authorised representative: -
Last updated: 02.08.2026 22:55

Manufacturer products View details

OD002

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: OncoDNA
Manufacturer SRN: BE-MF-000021570
UDI-DI: 05430003021576
Basic UDI-DI: B-05430003021576
Reference: OD002
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:51

Manufacturer products View details

05061059980366

ZENA MAX BCR/ABL Major Real Time PCR Quantitative Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Advanced Molecular Diagnostics Ltd
Manufacturer SRN: UK-MF-000043044
UDI-DI: 05061059980366
Basic UDI-DI: B-05061059980366
Reference: KD873977-100
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 02.08.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

Leica HER2 FISH Control Slides

TA9123

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331319340
Basic UDI-DI: B-05055331319340
Reference: TA9123
EMDN: W01060213
EMDN description: HER-2/NEU (BREAST CANCER)
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 02.08.2026 17:14

Manufacturer products Authorised representative products Authorised representative actors View details

Leica HER2 FISH System - 30 Test

TA9217

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331319005
Basic UDI-DI: B-05055331319005
Reference: TA9217
EMDN: W01060213
EMDN description: HER-2/NEU (BREAST CANCER)
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 02.08.2026 17:14

Manufacturer products Authorised representative products Authorised representative actors View details

GenetiSure Dx Postnatal Assay

K1201A

IVD Class CIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: 05700571108697
Basic UDI-DI: 570057R0403P3011C040000N8
Reference: K1201A
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:50

Manufacturer products Authorised representative products Authorised representative actors View details

Idylla™ EGFR Mutation Test

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: Biocartis NV
Manufacturer SRN: BE-MF-000003661
UDI-DI: 05415219000843
Basic UDI-DI: 5415219A0270CC
Reference: A0270/6
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:53

Manufacturer products View details

TarCET Kit Metabolic Panel

TarCET Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: MEDICOVER GENETICS LIMITED
Manufacturer SRN: CY-MF-000009381
UDI-DI: 05298004820198
Basic UDI-DI: 52980048MULTITN
Reference: ET201-00-2016
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Cyprus
Authorised representative: -
Last updated: 31.07.2026 09:49

Manufacturer products View details

IGH/MAF Plus v2 Translocation, Dual Fusion Probe