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439 device results listed.

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GeneProof Factor V Leiden PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161955023
Basic UDI-DI: B-08594161955023
Reference: FV/100
EMDN: W0106010103
EMDN description: FACTOR V LEIDEN
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:48

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

Genvinset® Factor V G1691A 96 tests

Genvinset® Factor V G1691A

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942703
Basic UDI-DI: B-08437016942703
Reference: GVS-FV-96
EMDN: W0106010103
EMDN description: FACTOR V LEIDEN
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:55

Manufacturer products View details

Genvinset® Factor V G1691A 48 tests

Genvinset® Factor V G1691A

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942383
Basic UDI-DI: B-08437016942383
Reference: GVS-FV-48
EMDN: W0106010103
EMDN description: FACTOR V LEIDEN
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:53

Manufacturer products View details

Genvinset® Factor V G1691A 24 tests

Genvinset® Factor V G1691A

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942376
Basic UDI-DI: B-08437016942376
Reference: GVS-FV-24
EMDN: W0106010103
EMDN description: FACTOR V LEIDEN
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:53

Manufacturer products View details

Adellgene® Myotonic Dystrophy Screening 16 tests

Adellgene® Myotonic Dystrophy Screening

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942338
Basic UDI-DI: B-08437016942338
Reference: AD-MD-16
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:53

Manufacturer products View details

Adellgene® Fragile X Screening 48 tests

Adellgene® Fragile X Screening

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942307
Basic UDI-DI: B-08437016942307
Reference: AD-FX-48
EMDN: W0106010104
EMDN description: FRAGILE X SYNDROME
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:53

Manufacturer products View details

Adellgene® Fragile X Screening 16 tests

Adellgene® Fragile X Screening

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942291
Basic UDI-DI: B-08437016942291
Reference: AD-FX-16
EMDN: W0106010104
EMDN description: FRAGILE X SYNDROME
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:53

Manufacturer products View details

Inherited CardioKitDx

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Health in Code, S.L.
Manufacturer SRN: ES-MF-000054848
UDI-DI: 08436589881853
Basic UDI-DI: B-08436589881853
Reference: IMG-390
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:50

Manufacturer products View details

08057723370615

SMART SNP MTHFR 1298 Positive Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370615
Basic UDI-DI: B-08057723370615
Reference: SNPD-032 CTRL
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:37

Manufacturer products View details

08057723370608

SMART SNP Coagulation Factors POSITIVE CONTROL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370608
Basic UDI-DI: B-08057723370608
Reference: SNPD-CF CTRL
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:37

Manufacturer products View details

08057723370110

SMART SNP FII FVL Direct Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370110
Basic UDI-DI: B-08057723370110
Reference: SNPD-034
EMDN: W0106010115
EMDN description: COMBINED FACTOR II / FACTOR V LEIDEN
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:35

Manufacturer products View details

08057723370103

SMART SNP MTHFR 677 Direct Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370103
Basic UDI-DI: B-08057723370103
Reference: SNPD-033
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:35

Manufacturer products View details

08057723370097

SMART SNP MTHFR 1298 Direct Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370097
Basic UDI-DI: B-08057723370097
Reference: SNPD-032
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:35

Manufacturer products View details

08057723370080

SMART SNP FVL Direct Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370080
Basic UDI-DI: B-08057723370080
Reference: SNPD-030
EMDN: W0106010103
EMDN description: FACTOR V LEIDEN
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:35

Manufacturer products View details

08057723370073

SMART SNP FII Direct Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370073
Basic UDI-DI: B-08057723370073
Reference: SNPD-029
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:35

Manufacturer products View details

SALSA MLPA Probemix P015 MECP2

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211480270
Basic UDI-DI: 872021148P0155H
Reference: P015-100R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 07.07.2026 15:44

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