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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

31.07.2026 19:58

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1000+ device results listed.

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AmoyDx® AutoExtract Kit (Whole Blood DNA)

48 tests/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Amoy Diagnostics Co., LTD.
Manufacturer SRN: CN-MF-000021843
UDI-DI: 06959094215026
Basic UDI-DI: 69590942A0040GC
Reference: 8.02.0152
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:04

Manufacturer products Authorised representative products Authorised representative actors View details

AmoyDx® AutoExtract Kit (FFPE RNA)

48 tests/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Amoy Diagnostics Co., LTD.
Manufacturer SRN: CN-MF-000021843
UDI-DI: 06959094215019
Basic UDI-DI: 69590942A0039GT
Reference: 8.02.0151
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:04

Manufacturer products Authorised representative products Authorised representative actors View details

48 tests/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468683
Basic UDI-DI: 5745000468EU0100170048AX
Reference: EU0100170048
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:40

Manufacturer products View details

96 tests/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468362
Basic UDI-DI: 5745000468EU0100090096BK
Reference: EU0100090096
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:40

Manufacturer products View details

50 tests/kit, 1000 tests/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468270
Basic UDI-DI: 5745000468MFG010040FV
Reference: MFG010040
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:40

Manufacturer products View details

50 tests/kit, 1000 tests/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468256
Basic UDI-DI: 5745000468MFG010038GA
Reference: MFG010038
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:40

Manufacturer products View details

120 tests/kit, 3600tests

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468218
Basic UDI-DI: 5745000468MFG010030FS
Reference: MFG010030
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:40

Manufacturer products View details

50 tests/kit, 400 tests/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468195
Basic UDI-DI: 5745000468MFG010033FY
Reference: MFG010033
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:40

Manufacturer products View details

35cycles/run, 1run

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468102
Basic UDI-DI: 5745000468MFG010010FL
Reference: MFG010010
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:40

Manufacturer products 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

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

UltraVerse Index Oligos (Type A)

UltraVerse Index Oligos

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: MEDICOVER GENETICS LIMITED
Manufacturer SRN: CY-MF-000009381
UDI-DI: 05298004820150
Basic UDI-DI: 52980048ULTRAUZ
Reference: EU100-00-100A
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Cyprus
Authorised representative: -
Last updated: 31.07.2026 09:49

Manufacturer products View details

TarCET PGT

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: MEDICOVER GENETICS LIMITED
Manufacturer SRN: CY-MF-000009381
UDI-DI: 05298004820075
Basic UDI-DI: 52980048PGTZB
Reference: ET202-00-2016
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Cyprus
Authorised representative: -
Last updated: 31.07.2026 09:49

Manufacturer products View details

VERACITY Advance

VERACITY NIPT Solution

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: MEDICOVER GENETICS LIMITED
Manufacturer SRN: CY-MF-000009381
UDI-DI: 05298004820013
Basic UDI-DI: 52980048NIPTTJ
Reference: EV101-00-2096
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: Cyprus
Authorised representative: -
Last updated: 31.07.2026 09:49

Manufacturer products View details

Library Quantification for Illumina®

Library Quantification for Illumina®

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: EntroGen, Inc.
Manufacturer SRN: US-MF-000022721
UDI-DI: 05060536830415
Basic UDI-DI: 506053683LIBQ0154
Reference: LIBQ-NGS
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Poland
Authorised representative: TANJA TOPOVSEK S.P.
Last updated: 31.07.2026 08:47

Manufacturer products Authorised representative products Authorised representative actors View details

Internal Quality Control Assay

Internal Quality Control Assay

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: EntroGen, Inc.
Manufacturer SRN: US-MF-000022721
UDI-DI: 05060536830262
Basic UDI-DI: 506053683IQCA014C
Reference: IQCA-RT50
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Northern Ireland
Authorised representative: TANJA TOPOVSEK S.P.
Last updated: 31.07.2026 08:47

Manufacturer products Authorised representative products Authorised representative actors View details

Yourgene® QST*R Base

Yourgene® QST*R

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Yourgene Health UK Ltd
Manufacturer SRN: GB-MF-000024810
UDI-DI: 05060402680076
Basic UDI-DI: 506040268ANM3
Reference: AN0PLB2
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: France
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:43

Manufacturer products Authorised representative products Authorised representative actors View details

Yourgene® Cystic Fibrosis Base

Yourgene® Cystic Fibrosis

IVD Class CIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Yourgene Health UK Ltd
Manufacturer SRN: GB-MF-000024810
UDI-DI: 05060402680007
Basic UDI-DI: 506040268CFLR
Reference: CF2EUB2
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: France
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:43

Manufacturer products Authorised representative products Authorised representative actors View details

IGH/MAF Plus v2 Translocation, Dual Fusion Probe

IGH/MAF Plus v2 Translocation, Dual Fusion Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906822
Basic UDI-DI: 50558449LPH108JL
Reference: CE-LPH 108
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 08:18

Manufacturer products Authorised representative products Authorised representative actors View details