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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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01.08.2026 18:27

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829 device results listed.

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Fast Fluorescence In Situ Hybridization Probe Kit

1p/19q deletion probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808257672W5
Basic UDI-DI: B-06971808257672W5
Reference: FP-045
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 16.07.2026 19:08

Manufacturer products Authorised representative products Authorised representative actors View details

Fast Fluorescence In Situ Hybridization Probe Kit

MYC (8q24)/BCL6 (3q27)/BCL2 (18q21) gene break apart probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808257634VV
Basic UDI-DI: B-06971808257634VV
Reference: FP-243-1
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 16.07.2026 19:08

Manufacturer products Authorised representative products Authorised representative actors View details

Fast Fluorescence In Situ Hybridization Probe Kit

MYC(8q24)/BCL6(3q27)/BCL2(18q21) gene break apart probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808257429VS
Basic UDI-DI: B-06971808257429VS
Reference: FP-243-2
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 16.07.2026 19:08

Manufacturer products Authorised representative products Authorised representative actors View details

Fast Fluorescence In Situ Hybridization Probe Kit

MDM2 gene amplification probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808256996WT
Basic UDI-DI: B-06971808256996WT
Reference: FP-054
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 16.07.2026 19:08

Manufacturer products Authorised representative products Authorised representative actors View details

Fast Fluorescence In Situ Hybridization Probe Kit

DDIT3 (12q13) gene rearrangement probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808256972WD
Basic UDI-DI: B-06971808256972WD
Reference: FP-052
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 16.07.2026 19:08

Manufacturer products Authorised representative products Authorised representative actors View details

Local Run Manager TruSight Oncology Comprehensive (EU) Analysis Module

TruSight™ Oncology Comprehensive (EU)

IVD generalIVDDOn the marketCompanion diagnosticsProfessional testing

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020309
Basic UDI-DI: B-00816270020309
Reference: 20051843
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 16.07.2026 13:32

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® MPL Kit

TRUPCR® MPL Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930054
Basic UDI-DI: 89080153043B1305KX
Reference: 3B1305/C
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 12:53

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Methylated Genes of Gastric Cancer（Real Time PCR）

30 tests per kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Excellen Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000010402
UDI-DI: 06970703931045
Basic UDI-DI: 697070393GAC00182
Reference: Diagnostic Kit for Methylated Genes of Gastric Cancer（Real Time PCR）
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 16.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Methylated Genes of Breast Cancer（Real Time PCR）

30 tests per kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Excellen Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000010402
UDI-DI: 06970703931038
Basic UDI-DI: 697070393BRC001BU
Reference: BRC-PCR-30-CE
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 16.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Methylated Genes of Colorectal Cancer（Real Time PCR）

30 tests per kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Excellen Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000010402
UDI-DI: 06970703931021
Basic UDI-DI: 697070393CRC001C9
Reference: CRC-PCR-30-CE
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 16.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Methylated Genes of Lung Cancer（Real Time PCR）

30 tests per kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Excellen Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000010402
UDI-DI: 06970703931014
Basic UDI-DI: 697070393LUC001GX
Reference: Diagnostic Kit for Methylated Genes of Lung Cancer（Real Time PCR）
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 16.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

ipsogen JAK2 RGQ PCR Kit

ipsogen JAK2 RGQ PCR Kit

IVD Class CIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228015444
Basic UDI-DI: 4053228RJAK2RGQ00000001RJ
Reference: 674623
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 16.07.2026 08:31

Manufacturer products View details

PredicineCARE Assay

PredicineCARE DeepSEA 1.7.3

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testingSingle use

Manufacturer: Predicine, Inc.
Manufacturer SRN: US-MF-000031888
UDI-DI: 00860013997625
Basic UDI-DI: 08600139976PDCA9999KER6
Reference: PD-CA9999KE
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 06:55

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Dx Target Test (DNA and RNA Panel)

Oncomine™ Dx Target Test

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302019620
Basic UDI-DI: 0190302A49756TV
Reference: A65534 （A65538)
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

UROMONITOR

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Infogene, Lda.
Manufacturer SRN: PT-MF-000047847
UDI-DI: D-infogene_CP
Basic UDI-DI: B-infogene_CP
Reference: UROM01
EMDN: W01060215
EMDN description: BLADDER CANCER DETECTION / MONITORING
First on market country: Portugal
Authorised representative: -
Last updated: 15.07.2026 14:19

Manufacturer products View details

Oncomine™ Dx Express Test Plasma cfTNA Control

Oncomine™ Dx Express Test Plasma cfTNA Control, a part of Ion Torrent™ Oncomine™ Dx Express Test

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: D-USMF000023929A5083783
Basic UDI-DI: B-USMF000023929A5083783
Reference: A50837 (A52168)
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Dx Express Test NTC Control

Oncomine™ Dx Express Test NTC Control, a part of Ion Torrent™ Oncomine™ Dx Express Test

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: D-USMF000023929A508367Z
Basic UDI-DI: B-USMF000023929A508367Z
Reference: A50836 (A52167, A52168)
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Dx Express Test FFPE RNA Control

Oncomine™ Dx Express Test FFPE RNA Control, a part of Ion Torrent™ Oncomine™ Dx Express Test

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: D-USMF000023929A508357X
Basic UDI-DI: B-USMF000023929A508357X
Reference: A50835 (A52167)
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Dx Express Test FFPE DNA Control

Oncomine™ Dx Express Test FFPE DNA Control, a part of Ion Torrent™ Oncomine™ Dx Express Test

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: D-USMF000023929A508347V
Basic UDI-DI: B-USMF000023929A508347V
Reference: A50834 (A52167)
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

geneMAP c-KIT D816V Mutation Detection Kit, 25T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405cKITRT25XK
Basic UDI-DI: B-TRMF000028405cKITRT25XK
Reference: cKIT-RT25
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:23

Manufacturer products View details