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836 device results listed.

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NRAS qPCR Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915SS007VFRZ
Basic UDI-DI: B-5713915SS007VFRZ
Reference: 1771;-76,-81,86,96;1801,-11,-16,-21,-26;2000,-05,-10,-15,-25,-30,-40,-45,-50,-55
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:48

Manufacturer products View details

EGFR qPCR Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915SS004V9QS
Basic UDI-DI: B-5713915SS004V9QS
Reference: 5675;5686;5550;5366;5575;5391;5545;5361;5555;5371;5540;5351;5570;5386;5560;5376;5565;5381;3075;5408
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:48

Manufacturer products View details

EGFR qPCR Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915SS003V7QH
Basic UDI-DI: B-5713915SS003V7QH
Reference: 5670;5681;2085;2081;3027;3071;2075;2071;2095;2091;2065;2061;3025;3021;3005;3001;3015;3011;3077;5398
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:48

Manufacturer products View details

BRAF qPCR Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915SS002V5Q8
Basic UDI-DI: B-5713915SS002V5Q8
Reference: 5525; 5530; 5535; 5336; 5341; 5346
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:48

Manufacturer products View details

BRAF qPCR Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915SS001V3PX
Basic UDI-DI: B-5713915SS001V3PX
Reference: 1398;1402;1400;1831;1836;1841
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:48

Manufacturer products View details

Fast Fluorescence In Situ Hybridization Probe Kit

CCND1 (BCL1) 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-06971808257788WR
Basic UDI-DI: B-06971808257788WR
Reference: FP-042
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

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