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23 device results listed.

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TruSight™ Cystic Fibrosis

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020149
Basic UDI-DI: 0081627002CYSTFIB8C
Reference: 20036925
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 03.08.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Yourgene® Cystic Fibrosis Base

Yourgene® Cystic Fibrosis

IVD Class CIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Yourgene Health UK Ltd
Manufacturer SRN: GB-MF-000024810
UDI-DI: 05060402680007
Basic UDI-DI: 506040268CFLR
Reference: CF2EUB2
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: France
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:43

Manufacturer products Authorised representative products Authorised representative actors View details

08033629920871

CF PLUS

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629920871
Basic UDI-DI: B-08033629920871
Reference: AC089
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Italy
Authorised representative: -
Last updated: 25.07.2026 00:52

Manufacturer products View details

08033629920345

CF DEL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629920345
Basic UDI-DI: B-08033629920345
Reference: AC033
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Italy
Authorised representative: -
Last updated: 25.07.2026 00:52

Manufacturer products View details

08033629924473

CF FAST

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629924473
Basic UDI-DI: 803362992GENSCREENKT
Reference: AA1358/48A
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 11:47

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-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

Genvinset® deltaF508 96 tests

Genvinset® deltaF508

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942901
Basic UDI-DI: B-08437016942901
Reference: GVS-DF508-96
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:55

Manufacturer products View details

Genvinset® deltaF508 48 tests

Genvinset® deltaF508

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSterile

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942895
Basic UDI-DI: B-08437016942895
Reference: GVS-DF508-48
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:55

Manufacturer products View details

Genvinset® deltaF508 24 tests

Genvinset® deltaF508

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942888
Basic UDI-DI: B-08437016942888
Reference: GVS-DF508-24
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:55

Manufacturer products View details

08033629920321

Cystic Fibrosis

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629920321
Basic UDI-DI: B-08033629920321
Reference: AC023/25
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 12:14

Manufacturer products View details

Devyser CFTR 68

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040630648
Basic UDI-DI: B-07350040630648
Reference: 8-A045
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Sweden
Authorised representative: -
Last updated: 07.07.2026 04:13

Manufacturer products View details

Devyser CFTR 68

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040630624
Basic UDI-DI: B-07350040630624
Reference: 8-A045-8
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Sweden
Authorised representative: -
Last updated: 07.07.2026 04:13

Manufacturer products View details

Devyser CFTR 68

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040630617
Basic UDI-DI: B-07350040630617
Reference: 8-A045-24
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Sweden
Authorised representative: -
Last updated: 07.07.2026 04:13

Manufacturer products View details

GeneMind

144 tests/kit

IVD generalIVDDOn the marketKitReagentSingle use

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584022
Basic UDI-DI: B-06974968584022
Reference: L000154
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

GeneMind

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968583568
Basic UDI-DI: B-06974968583568
Reference: L000106
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

MutaREAL® Cystic Fibrosis

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598010833
Basic UDI-DI: B-04050598010833
Reference: KF290832
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:49

Manufacturer products View details

MutaREAL® Cystic Fibrosis

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598010826
Basic UDI-DI: B-04050598010826
Reference: KF290896
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:49

Manufacturer products View details

MutaPLATE® Cystic Fibrosis

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598008731
Basic UDI-DI: B-04050598008731
Reference: KF190896
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:47

Manufacturer products View details

MutaPLATE® Cystic Fibrosis

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598008724
Basic UDI-DI: B-04050598008724
Reference: KF190832
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:47

Manufacturer products View details