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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

D-529012PL

48 Rxns/kit ，96 Rxns/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-529012PL
Basic UDI-DI: B-529012PL
Reference: 529012/529013
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 17.07.2026 02:37

Manufacturer products Authorised representative products Authorised representative actors View details

iDNA PGx CNS kit

Ref. 002

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iDNA LABORATORIES ΙΔΙΩΤΙΚΟ ΔΙΑΓΝΩΣΤΙΚΟ ΕΡΓΑΣΤΗΡΙΟ ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ
Manufacturer SRN: GR-MF-000033624
UDI-DI: D-5200423500223L4
Basic UDI-DI: B-5200423500223L4
Reference: Ref.002
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Greece
Authorised representative: -
Last updated: 17.07.2026 02:36

Manufacturer products View details

iDNA Cardio Health

Ref.005

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: iDNA LABORATORIES ΙΔΙΩΤΙΚΟ ΔΙΑΓΝΩΣΤΙΚΟ ΕΡΓΑΣΤΗΡΙΟ ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ
Manufacturer SRN: GR-MF-000033624
UDI-DI: 52004235002160
Basic UDI-DI: B-52004235002160
Reference: Ref.005
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Greece
Authorised representative: -
Last updated: 17.07.2026 02:34

Manufacturer products View details

Xpert®

Xpert® NPM1 Mutation

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940008390
Basic UDI-DI: B-07332940008390
Reference: GXNPM1-CE-10
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors 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

Xpert®

Xpert® FII & FV

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940000240
Basic UDI-DI: B-07332940000240
Reference: GXFIIFV-10
EMDN: W0106010115
EMDN description: COMBINED FACTOR II / FACTOR V LEIDEN
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

Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)

384 tests/kit (Pre-packaged)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584312
Basic UDI-DI: B-06974968584312
Reference: L000162-P
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 19:13

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)

96 tests/kit (Pre-packaged)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584305
Basic UDI-DI: B-06974968584305
Reference: L000161-P
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 19:13

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)

64 tests/kit (Pre-packaged)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584299
Basic UDI-DI: B-06974968584299
Reference: L000160-P
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 19:13

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)

48tests/kit (Pre-packaged)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584282
Basic UDI-DI: B-06974968584282
Reference: L000159-P
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 19:13

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)

32 tests/kit (Pre-packaged)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584275
Basic UDI-DI: B-06974968584275
Reference: L000158-P
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 19:13

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)

24 tests/kit (Pre-packaged)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584268
Basic UDI-DI: B-06974968584268
Reference: L000157-P
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 19:13

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

06970895476393

Human Telomere Length Real Time PCR Detection Kit

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895476393
Basic UDI-DI: B-06970895476393
Reference: TP060104T2024
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Czechia
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 19:03

Manufacturer products Authorised representative products Authorised representative actors View details

06970895476256

Kit de detección por PCR en tiempo real de la longitud de los telómeros humanos

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895476256
Basic UDI-DI: B-06970895476256
Reference: TP060104T2024
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Czechia
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 19:03

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