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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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Last updated

01.08.2026 05:11

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Device

2988376

Actor

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Certificate

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Active filter:EMDN:W010602

829 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
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
Del(5q) Deletion Probe

Del(5q) Deletion Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Cytocell Limited
Manufacturer SRN
GB-MF-000016893
UDI-DI
05055844906365
Basic UDI-DI
50558449LPH024JD
Reference
CE-LPH 024
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
CBFß (CBFB)/MYH11 Translocation, Dual Fusion Probe

CBFß (CBFB)/MYH11 Translocation, Dual Fusion Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Cytocell Limited
Manufacturer SRN
GB-MF-000016893
UDI-DI
05055844906341
Basic UDI-DI
50558449LPH022J9
Reference
CE-LPH 022
EMDN
W01060211
EMDN description
INV (16)
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(20q) Deletion Probe

Del(20q) Deletion Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Cytocell Limited
Manufacturer SRN
GB-MF-000016893
UDI-DI
05055844906327
Basic UDI-DI
50558449LPH020J5
Reference
CE-LPH 020
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
MLL (KMT2A) Breakapart Probe

MLL (KMT2A) Breakapart Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Cytocell Limited
Manufacturer SRN
GB-MF-000016893
UDI-DI
05055844906242
Basic UDI-DI
50558449LPH013J8
Reference
CE-LPH 013
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
ATM Deletion Probe

ATM Deletion Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Cytocell Limited
Manufacturer SRN
GB-MF-000016893
UDI-DI
05055844906204
Basic UDI-DI
50558449LPH011J4
Reference
CE-LPH 011
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) Translocation, Dual Fusion Probe

BCR/ABL (ABL1) Translocation, Dual Fusion Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Cytocell Limited
Manufacturer SRN
GB-MF-000016893
UDI-DI
05055844906181
Basic UDI-DI
50558449LPH007JD
Reference
CE-LPH 007
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
XCE 12 blue

XCE 12 blue

IVD Class CIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
MetaSystems Probes GmbH
Manufacturer SRN
DE-MF-000006315
UDI-DI
04251315813106
Basic UDI-DI
42513158D-0812IVDJ8
Reference
D-0812-050-BL
EMDN
W01060299
EMDN description
TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country
Germany
Authorised representative
-
Last updated
31.07.2026 01:00
Manufacturer productsView details