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EUDAMED Device Search

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

Last updated

17.07.2026 02:58

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251 device results listed.

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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: 05055844906501
Basic UDI-DI: 50558449LPH038JQ
Reference: CE-LPH 038
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:47

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: -
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:47

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: -
EMDN description: P53
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:47

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: -
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:47

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: -
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:46

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: -
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:46

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: -
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:46

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: -
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:46

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: -
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:46

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: -
EMDN description: INV (16)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:46

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: -
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:46

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: -
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:46

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: -
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:46

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: -
EMDN description: T (9;22)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

Prenatal 13 and 21 Enumeration Probe kit

Prenatal 13 and 21 Enumeration Probe kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906044
Basic UDI-DI: 50558449LPA003GL
Reference: CE-LPA 003
EMDN: -
EMDN description: PÄTAU SYNDROME
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

STROMATOLYSER-WH

STROMATOLYSER-WH

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 14987562509109
Basic UDI-DI: 4987562STROMATOLYSERWHPH
Reference: 974-0521-6
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:13

Manufacturer products Authorised representative products Authorised representative actors View details

STROMATOLYSER-4DS

STROMATOLYSER-4DS

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 14987562509086
Basic UDI-DI: 4987562STROMATOLYSER4DSCS
Reference: 054-3331-0
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:13

Manufacturer products Authorised representative products Authorised representative actors View details

UF- Fluorocell SF

UF- Fluorocell SF

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 14987562509062
Basic UDI-DI: 4987562UF-FluorocellSFMC
Reference: AV083519
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:13

Manufacturer products Authorised representative products Authorised representative actors View details

UF- Fluorocell CR

UF- Fluorocell CR

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 14987562509055
Basic UDI-DI: 4987562UF-FluorocellCRLL
Reference: BW056982
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

UC-1100 Semi-Automated Urine Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562527724
Basic UDI-DI: 4987562UC-1100RE
Reference: CM509660
EMDN: -
EMDN description: URINE STRIP READERS
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details