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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

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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®

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

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