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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

Gluten DQuick DResolution v4

RT-59v4

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Clonit srl
Manufacturer SRN: IT-MF-000022196
UDI-DI: 08057680910909
Basic UDI-DI: 805768091GlutenDQ_02E3
Reference: RT-59v4_96
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 15:11

Manufacturer products View details

Gluten DQuick DResolution v4

RT-59v4

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Clonit srl
Manufacturer SRN: IT-MF-000022196
UDI-DI: 08057680910893
Basic UDI-DI: 805768091GlutenDQ_02E3
Reference: RT-59v4
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 15:11

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DPYD (5 gene mutations)

RT-104

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Clonit srl
Manufacturer SRN: IT-MF-000022196
UDI-DI: 08057680910763
Basic UDI-DI: 805768091DPYD_01XD
Reference: RT-104
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 15:11

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

Myriapod NGS PGx Sign panel

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIATECH PHARMACOGENETICS SRL
Manufacturer SRN: IT-MF-000018670
UDI-DI: 08057289091238
Basic UDI-DI: 8057289090403CNGX037XY
Reference: NGX037
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 15:11

Manufacturer products View details

Eu-Gen MTHFR Dual-Type (25 Test)

Eu-Gen MTHFR Dual-Type

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Eurospital Spa
Manufacturer SRN: IT-MF-000028468
UDI-DI: 08028169208916
Basic UDI-DI: 802816920CW01060402055E
Reference: 9463S
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:24

Manufacturer products View details

Eu-Gen MTHFR Dual-Type (100 Test)

Eu-Gen MTHFR Dual-Type

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Eurospital Spa
Manufacturer SRN: IT-MF-000028468
UDI-DI: 08028169208909
Basic UDI-DI: 802816920CW01060402055E
Reference: 9463
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:24

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

LactoGen Controls

LactoGen

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Eurospital Spa
Manufacturer SRN: IT-MF-000028468
UDI-DI: 08028169205786
Basic UDI-DI: 802816920CW010604020258
Reference: 9242
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:24

Manufacturer products View details

LactoGen

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Eurospital Spa
Manufacturer SRN: IT-MF-000028468
UDI-DI: 08028169205779
Basic UDI-DI: 802816920CW010604020258
Reference: 9241
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:24

Manufacturer products View details

Xeligen® XL

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Eurospital Spa
Manufacturer SRN: IT-MF-000028468
UDI-DI: 08028169203454
Basic UDI-DI: 802816920CW01060402035A
Reference: 9186
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
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