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980 device results listed.

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D-A071D6

PHASIFY™ Endometrial Cancer Subtyping Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A071D6
Basic UDI-DI: B-A071D6
Reference: PHASIFY™ Endometrial Cancer Subtyping Kit
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

Idylla™ MSI Test

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Biocartis NV
Manufacturer SRN: BE-MF-000003661
UDI-DI: 15415219000550
Basic UDI-DI: B-15415219000550
Reference: A0100/6
EMDN: W01060214
EMDN description: COLORECTAL CANCER (MSI-H / DMMR)
First on market country: Belgium
Authorised representative: -
Last updated: 24.07.2026 00:36

Manufacturer products View details

D-A070D4

PHASIFY™ Endometrial Cancer Methylation Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A070D4
Basic UDI-DI: B-A070D4
Reference: PHASIFY™ Endometrial Cancer Methylation Test
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-A068DH

PHASIFY™ HPV PCR Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A068DH
Basic UDI-DI: B-A068DH
Reference: PHASIFY™ HPV PCR Test
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-A069DK

PHASIFY™ ASCL1,LHX8 and SOX1 Genetic methylation PCR Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A069DK
Basic UDI-DI: B-A069DK
Reference: PHASIFY™ ASCL1,LHX8 and SOX1 Genetic methylation PCR Test
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

SensiScreen

Liquid KIT qPCR Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915SS014VCRK
Basic UDI-DI: B-5713915SS014VCRK
Reference: 5800; 5581
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:49

Manufacturer products View details

SensiScreen

KIT qPCR Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915SS013VARA
Basic UDI-DI: B-5713915SS013VARA
Reference: 1154; 1846
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:49

Manufacturer products View details

SensiScreen

PIK3CA qPCR Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915SS010V4Q3
Basic UDI-DI: B-5713915SS010V4Q3
Reference: 5585; 5586; 5587; 5590; 5591; 5592; 5600; 5601
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:49

Manufacturer products View details

SensiScreen

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

SensiScreen

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

SensiScreen

KRAS qPCR Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915SS005VBRF
Basic UDI-DI: B-5713915SS005VBRF
Reference: 1900;1701;1905;1706;1910;1711;1915;1716;1925;1726;1930;1731;1940;1741;1945;1746;1955;1756;1960;1761
EMDN: W01060202
EMDN description: K-RAS
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:48

Manufacturer products View details

SensiScreen

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

SensiScreen

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

SensiScreen

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

Xpert®

Xpert® Bladder Cancer Monitor

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940002282
Basic UDI-DI: B-07332940002282
Reference: GXBLAD-CM-CE-10
EMDN: W01060215
EMDN description: BLADDER CANCER DETECTION / MONITORING
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert®

Xpert® Bladder Cancer Detection

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940002268
Basic UDI-DI: B-07332940002268
Reference: GXBLAD-CD-CE-10
EMDN: W01060215
EMDN description: BLADDER CANCER DETECTION / MONITORING
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors 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

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