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INDICAID™ Cervical Cancer Methylation Test (vaginal or cervical swab, gene sequencing technology)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A023CT
Basic UDI-DI: B-A023CT
Reference: INDICAID™ Cervical Cancer Methylation Test (vaginal or cervical swab, gene sequencing technology)
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: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Cervical Cancer Methylation Test (vaginal or cervical swab, PCR-fluorescent probe method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A022CR
Basic UDI-DI: B-A022CR
Reference: INDICAID™ Cervical Cancer Methylation Test (vaginal or cervical swab, PCR-fluorescent probe method)
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: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-9022B8

Unique Dual Index Plate for Illumina®

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: NimaGen BV
Manufacturer SRN: NL-MF-000022926
UDI-DI: D-9022B8
Basic UDI-DI: B-9022B8
Reference: IDX096-U0X(X)-I
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:55

Manufacturer products View details

D-9021B6

Partner and Localiser of BRCA2 (PALB2) Library Prep Kit for Illumina®

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: NimaGen BV
Manufacturer SRN: NL-MF-000022926
UDI-DI: D-9021B6
Basic UDI-DI: B-9021B6
Reference: RC-PALB096-I
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:55

Manufacturer products View details

D-9020B4

Tumour Protein p53 gene (TP53) Library Prep Kit for Illumina®

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: NimaGen BV
Manufacturer SRN: NL-MF-000022926
UDI-DI: D-9020B4
Basic UDI-DI: B-9020B4
Reference: RC-TP53096-I
EMDN: W01060201
EMDN description: P53
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:55

Manufacturer products View details

D-9018BH

Cystic Fibrosis Transmembrane Conductance Regulator Gene (CFTR) Library Prep Kit for Illumina®

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: NimaGen BV
Manufacturer SRN: NL-MF-000022926
UDI-DI: D-9018BH
Basic UDI-DI: B-9018BH
Reference: RC-CFTR096-I
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:55

Manufacturer products View details

D-9019BK

Breast Cancer 1 (BRCA1) and Breast Cancer 2 (BRCA2) Library Prep Kit for Illumina®

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: NimaGen BV
Manufacturer SRN: NL-MF-000022926
UDI-DI: D-9019BK
Basic UDI-DI: B-9019BK
Reference: RC-BRCA096-I
EMDN: W01060203
EMDN description: BRCA 1+2
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:54

Manufacturer products View details

D-9017BF

Cystic Fibrosis Transmembrane Conductance Regulator Gene (CFTR) Mutation Hotspots Library Prep Kit for Illumina®

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: NimaGen BV
Manufacturer SRN: NL-MF-000022926
UDI-DI: D-9017BF
Basic UDI-DI: B-9017BF
Reference: RC-CFHS096-I
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:54

Manufacturer products View details

D-90085-RTFE

EliGene® CELIAC DQ PLUS RT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ELISABETH PHARMACON, spol. s r.o.
Manufacturer SRN: CZ-MF-000025244
UDI-DI: D-90085-RTFE
Basic UDI-DI: B-90085-RTFE
Reference: 90085-RT
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Czechia
Authorised representative: -
Last updated: 12.07.2026 20:54

Manufacturer products View details

D-90071-RTE7

EliGene® Coeliac 3.0 RT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ELISABETH PHARMACON, spol. s r.o.
Manufacturer SRN: CZ-MF-000025244
UDI-DI: D-90071-RTE7
Basic UDI-DI: B-90071-RTE7
Reference: 90071-RT
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Czechia
Authorised representative: -
Last updated: 12.07.2026 20:54

Manufacturer products View details

KMRtrack® KMR057

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: D-8844342-57BL
Basic UDI-DI: B-8844342-57BL
Reference: 8844342-57
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:29

Manufacturer products View details

KMRtrack® KMR056

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: D-8844342-56BJ
Basic UDI-DI: B-8844342-56BJ
Reference: 8844342-56
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:29

Manufacturer products View details

KMRtrack® KMR055

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: D-8844342-55BG
Basic UDI-DI: B-8844342-55BG
Reference: 8844342-55
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:29

Manufacturer products View details

KMRtrack® KMR054

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: D-8844342-54BE
Basic UDI-DI: B-8844342-54BE
Reference: 8844342-54
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:29

Manufacturer products View details

KMRtrack® KMR053

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: D-8844342-53BC
Basic UDI-DI: B-8844342-53BC
Reference: 844342-53
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:29

Manufacturer products View details

KMRtrack® KMR052

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: D-8844342-52BA
Basic UDI-DI: B-8844342-52BA
Reference: 844342-52
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:29

Manufacturer products View details

KMRtrack® KMR051

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: D-8844342-51B8
Basic UDI-DI: B-8844342-51B8
Reference: 8844342-51
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:29

Manufacturer products View details

KMRtrack® KMR050

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: D-8844342-50B6
Basic UDI-DI: B-8844342-50B6
Reference: 8844342-50
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:29

Manufacturer products View details

KMRtrack® KMR049

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: D-8844342-49BM
Basic UDI-DI: B-8844342-49BM
Reference: 8844342-49
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:29

Manufacturer products View details

KMRtrack® KMR048

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: D-8844342-48BK
Basic UDI-DI: B-8844342-48BK
Reference: 8844342-48
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:29

Manufacturer products View details