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314 device results listed.

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Adellgene® Friedreich's Ataxia 16 tests

Adellgene® Friedreich's Ataxia

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942352
Basic UDI-DI: 8437016942AD-FAWG
Reference: AD-FA-16
EMDN: W0106010112
EMDN description: FRIEDREICH'S ATAXIA
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:35

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Adellgene® Myotonic Dystrophy Confirmatory 16 tests

Adellgene® Myotonic Dystrophy Confirmatory

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942345
Basic UDI-DI: 8437016942AD-MDCZG
Reference: AD-MD-C-16
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:35

Manufacturer products View details

Genvinset® HFE S65C 48 tests

Genvinset® HFE S65C

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942208
Basic UDI-DI: 8437016942GVS-S65CZR
Reference: GVS-S65C-48
EMDN: W0106010105
EMDN description: HAEMOCHROMATOSIS
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:35

Manufacturer products View details

Genvinset® HFE S65C 24 tests

Genvinset® HFE S65C

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942192
Basic UDI-DI: 8437016942GVS-S65CZR
Reference: GVS-S65C-24
EMDN: W0106010105
EMDN description: HAEMOCHROMATOSIS
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:35

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A1AT Genotyping Test Reagents

A1AT Genotyping Test

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457101
Basic UDI-DI: 8437013457Gentest001QK
Reference: 1292320000
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:34

Manufacturer products View details

A1AT Genotyping Test Reagents

A1AT Genotyping Test

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457095
Basic UDI-DI: 8437013457Gentest001QK
Reference: 1292380000
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:34

Manufacturer products View details

Genvinset® Thrombo panel 96 test

Genvinset® Thrombo panel 24 test

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08436615250073
Basic UDI-DI: 843661525GVS-THPUG
Reference: GVS-THP-96
EMDN: W0106010116
EMDN description: OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:34

Manufacturer products View details

Genvinset® Thrombo panel 48 test

Genvinset® Thrombo panel 24 test

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08436615250066
Basic UDI-DI: 843661525GVS-THPUG
Reference: GVS-THP-48
EMDN: W0106010116
EMDN description: OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:34

Manufacturer products View details

Genvinset® Thrombo panel 24 test

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08436615250059
Basic UDI-DI: 843661525GVS-THPUG
Reference: GVS-THP-24
EMDN: W0106010116
EMDN description: OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:34

Manufacturer products View details

Genvinset® PAI-1/FXIII multiplex 96 test

Genvinset® PAI-1/FXIII multiplex 24 test

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08436615250028
Basic UDI-DI: 843661525GVS-PAI/F13UA
Reference: GVS-PAI/F13-96
EMDN: W0106010116
EMDN description: OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:34

Manufacturer products View details

Genvinset® PAI-1/FXIII multiplex 48 test

Genvinset® PAI-1/FXIII multiplex 24 test

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08436615250011
Basic UDI-DI: 843661525GVS-PAI/F13UA
Reference: GVS-PAI/F13-48
EMDN: W0106010116
EMDN description: OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:34

Manufacturer products View details

Genvinset® PAI-1/FXIII multiplex 24 test

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08436615250004
Basic UDI-DI: 843661525GVS-PAI/F13UA
Reference: GVS-PAI/F13-24
EMDN: W0106010116
EMDN description: OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:33

Manufacturer products View details

Duplicα RealTime Mix & Match Factor V G1691A Kit QS

EER038032

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Clonit srl
Manufacturer SRN: IT-MF-000022196
UDI-DI: 08057680910497
Basic UDI-DI: 805768091FVG1691_M01CH
Reference: EER038032QS
EMDN: W0106010103
EMDN description: FACTOR V LEIDEN
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 15:11

Manufacturer products View details

Duplica Real Time Mix & Match FACTOR V G1691A Kit

EER038032

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Clonit srl
Manufacturer SRN: IT-MF-000022196
UDI-DI: 08057680910015
Basic UDI-DI: 805768091FVG1691_M01CH
Reference: EER038032
EMDN: W0106010103
EMDN description: FACTOR V LEIDEN
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 15:11

Manufacturer products View details

Eu-Gen FII/FV Type (25 T)

Eu-Gen FII/FV Type

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Eurospital Spa
Manufacturer SRN: IT-MF-000028468
UDI-DI: 08028169208404
Basic UDI-DI: 802816920CW01060402045C
Reference: 9462S
EMDN: W0106010115
EMDN description: COMBINED FACTOR II / FACTOR V LEIDEN
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:24

Manufacturer products View details

Eu-Gen FII/FV Type

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Eurospital Spa
Manufacturer SRN: IT-MF-000028468
UDI-DI: 08028169208275
Basic UDI-DI: 802816920CW01060402045C
Reference: 9462
EMDN: W0106010115
EMDN description: COMBINED FACTOR II / FACTOR V LEIDEN
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:24

Manufacturer products View details

Devyser Thalassemia v2

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040635209
Basic UDI-DI: 7350040638R117RJ
Reference: 8-R117-48
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Sweden
Authorised representative: -
Last updated: 30.06.2026 12:48

Manufacturer products View details

Devyser Thalassemia v2

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040635193
Basic UDI-DI: 7350040638R117RJ
Reference: 8-R117-24
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Sweden
Authorised representative: -
Last updated: 30.06.2026 12:48

Manufacturer products View details

DEVYSER CFTR

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040632178
Basic UDI-DI: 7350040638R101R3
Reference: 8-R101-96
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Sweden
Authorised representative: -
Last updated: 30.06.2026 12:48

Manufacturer products View details

DEVYSER CFTR

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040632161
Basic UDI-DI: 7350040638R101R3
Reference: 8-R101-24
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Sweden
Authorised representative: -
Last updated: 30.06.2026 12:48

Manufacturer products View details