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XL Iso(17q)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315806108
Basic UDI-DI: B-04251315806108
Reference: D-5048-100-OG
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:43

Manufacturer products View details

Genexpath

SarcomaFusion 48U

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genexpath
Manufacturer SRN: FR-MF-000029325
UDI-DI: 03770026953075
Basic UDI-DI: B-03770026953075
Reference: GEP-SF48
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:33

Manufacturer products View details

Genexpath

SarcomaFusion 24U

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genexpath
Manufacturer SRN: FR-MF-000029325
UDI-DI: 03770026953068
Basic UDI-DI: B-03770026953068
Reference: GEP-SF24
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:33

Manufacturer products View details

Genexpath

SarcomaFusion 16U

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genexpath
Manufacturer SRN: FR-MF-000029325
UDI-DI: 03770026953051
Basic UDI-DI: B-03770026953051
Reference: GEP-SF16
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:33

Manufacturer products View details

Genexpath

SarcomaFusion 8U

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genexpath
Manufacturer SRN: FR-MF-000029325
UDI-DI: 03770026953044
Basic UDI-DI: B-03770026953044
Reference: GEP-SF08
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:33

Manufacturer products View details

Genexpath

LymphoSign 48U

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genexpath
Manufacturer SRN: FR-MF-000029325
UDI-DI: 03770026953037
Basic UDI-DI: B-03770026953037
Reference: GEP-LS48
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:33

Manufacturer products View details

Genexpath

LymphoSign 24U

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genexpath
Manufacturer SRN: FR-MF-000029325
UDI-DI: 03770026953020
Basic UDI-DI: B-03770026953020
Reference: GEP-LS24
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:33

Manufacturer products View details

Genexpath

LymphoSign 16U

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genexpath
Manufacturer SRN: FR-MF-000029325
UDI-DI: 03770026953013
Basic UDI-DI: B-03770026953013
Reference: GEP-LS16
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:33

Manufacturer products View details

Genexpath

LymphoSign 8U

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genexpath
Manufacturer SRN: FR-MF-000029325
UDI-DI: 03770026953006
Basic UDI-DI: B-03770026953006
Reference: GEP-LS08
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:33

Manufacturer products View details

OncoMate® 5C Matrix Standard

MD3850

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Promega Corporation
Manufacturer SRN: US-MF-000034520
UDI-DI: 00849811057137
Basic UDI-DI: B-00849811057137
Reference: MD3850
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 05.07.2026 10:50

Manufacturer products Authorised representative products Authorised representative actors View details

OncoMate® MSI Dx Analysis System

MD3140

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Promega Corporation
Manufacturer SRN: US-MF-000034520
UDI-DI: 00849811057120
Basic UDI-DI: B-00849811057120
Reference: MD3140
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 05.07.2026 10:50

Manufacturer products Authorised representative products Authorised representative actors View details

TruSight™ Oncology Comprehensive (EU) kit

20063092

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020620
Basic UDI-DI: B-00816270020620
Reference: 20063092
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: 04.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

Human TEL-AML1 Fusion Gene Mutation Detection Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-0000128072030E3PF
Basic UDI-DI: B-0000128072030E3PF
Reference: HWTS-TM016
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: 04.07.2026 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® HPV 16 & 18 Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304743
Basic UDI-DI: 89080153043B1276LH
Reference: 3B1276/C
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:07

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® HPV High Risk Genotyping Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304712
Basic UDI-DI: 89080153043B1423L6
Reference: 3B1423/C
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:07

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® KRAS Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304637
Basic UDI-DI: 89080153043B1295LM
Reference: 3B1295
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:07

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® EGFR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304613
Basic UDI-DI: 89080153043B1311KS
Reference: 3B1311
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:07

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® NRAS Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304668
Basic UDI-DI: 89080153043B1296LP
Reference: 3B1296
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:07

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® NPM1 Quantitative Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304590
Basic UDI-DI: 89080153043B325NG
Reference: 3B325
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® ALL Panel Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304576
Basic UDI-DI: 89080153043B1405L4
Reference: 3B1405
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details