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Last updated

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Active filter:EMDN:W0106

1000+ device results listed.

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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 productsAuthorised representative productsAuthorised representative actorsView 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 productsView 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 productsView 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 productsView details
TarCET PGT

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 productsView 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 productsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details
CBFB Breakapart Probe

CBFB Breakapart Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Cytocell Limited
Manufacturer SRN
GB-MF-000016893
UDI-DI
05055844906761
Basic UDI-DI
50558449LPH089K9
Reference
CE-LPH 089
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 productsAuthorised representative productsAuthorised representative actorsView details
FAST PML/RARα (RARA) Translocation, Dual Fusion Probe

FAST PML/RARα (RARA) Translocation, Dual Fusion Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Cytocell Limited
Manufacturer SRN
GB-MF-000016893
UDI-DI
05055844906600
Basic UDI-DI
50558449LPH064JR
Reference
CE-LPH 064
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 productsAuthorised representative productsAuthorised representative actorsView details
P53 (TP53)/ATM Combination Deletion Probe

P53 (TP53)/ATM Combination Deletion Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Cytocell Limited
Manufacturer SRN
GB-MF-000016893
UDI-DI
05055844906587
Basic UDI-DI
50558449LPH052JJ
Reference
CE-LPH 052
EMDN
W01060201
EMDN description
P53
First on market country
Germany
Authorised representative
Sysmex Europe SE
Last updated
31.07.2026 08:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
CKS1B/CDKN2C (P18) Amplification/Deletion Probe

CKS1B/CDKN2C (P18) Amplification/Deletion Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Cytocell Limited
Manufacturer SRN
GB-MF-000016893
UDI-DI
05055844906525
Basic UDI-DI
50558449LPH039JS
Reference
CE-LPH 039
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 productsAuthorised representative productsAuthorised representative actorsView details
BCR/ABL (ABL1) Plus Translocation, Dual Fusion Probe

BCR/ABL (ABL1) Plus Translocation, Dual Fusion Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Cytocell Limited
Manufacturer SRN
GB-MF-000016893
UDI-DI
05055844906518
Basic UDI-DI
50558449LPH038JQ
Reference
CE-LPH 038-S
EMDN
W01060208
EMDN description
T (9;22)
First on market country
Germany
Authorised representative
Sysmex Europe SE
Last updated
31.07.2026 08:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
EVI1 (MECOM) Breakapart Probe

EVI1 (MECOM) Breakapart Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Cytocell Limited
Manufacturer SRN
GB-MF-000016893
UDI-DI
05055844906488
Basic UDI-DI
50558449LPH036JL
Reference
CE-LPH 036
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 productsAuthorised representative productsAuthorised representative actorsView details
AML1 (RUNX1) Breakapart Probe

AML1 (RUNX1) Breakapart Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Cytocell Limited
Manufacturer SRN
GB-MF-000016893
UDI-DI
05055844906426
Basic UDI-DI
50558449LPH027JK
Reference
CE-LPH 027
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 productsAuthorised representative productsAuthorised representative actorsView details
AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion Probe

AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Cytocell Limited
Manufacturer SRN
GB-MF-000016893
UDI-DI
05055844906402
Basic UDI-DI
50558449LPH026JH
Reference
CE-LPH 026
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 productsAuthorised representative productsAuthorised representative actorsView details
Del(7q) Deletion Probe

Del(7q) Deletion Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Cytocell Limited
Manufacturer SRN
GB-MF-000016893
UDI-DI
05055844906389
Basic UDI-DI
50558449LPH025JF
Reference
CE- LPH 025
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 productsAuthorised representative productsAuthorised representative actorsView details