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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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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 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

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

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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View details

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 products View details