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312 device results listed.

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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

SALSA MLPA Probemix P102 HBB

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211481376
Basic UDI-DI: 872021148P1025D
Reference: P102-025R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 28.07.2026 01:23

Manufacturer products View details

SALSA MLPA Probemix P102 HBB

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211481383
Basic UDI-DI: 872021148P1025D
Reference: P102-050R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 27.07.2026 22:57

Manufacturer products View details

SALSA MLPA Probemix P102 HBB

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211481390
Basic UDI-DI: 872021148P1025D
Reference: P102-100R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 27.07.2026 22:57

Manufacturer products View details

08033629921106

Beta Globin PlusTest

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629921106
Basic UDI-DI: B-08033629921106
Reference: AC104
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Italy
Authorised representative: -
Last updated: 25.07.2026 00:52

Manufacturer products View details

08033629920994

Alfa Globin Test

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629920994
Basic UDI-DI: B-08033629920994
Reference: AC099
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Italy
Authorised representative: -
Last updated: 25.07.2026 00:52

Manufacturer products 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

08033629920741

Beta Globin Test

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629920741
Basic UDI-DI: B-08033629920741
Reference: AC091
EMDN: W0106010111
EMDN description: THALASSAEMIA
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

08033629922165

FATTORE II (G20210) Real time (FRET)

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629922165
Basic UDI-DI: 803362992GENPREDQ3
Reference: AA831/50A
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 23:02

Manufacturer products View details

08033629923964

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629923964
Basic UDI-DI: 803362992GENPREDQ3
Reference: FA097/10
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: -
Authorised representative: -
Last updated: 23.07.2026 22:38

Manufacturer products View details

One Step Sickle cell Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: D-L11-SCD01C4XB
Basic UDI-DI: B-L11-SCD01C4XB
Reference: L11-SCD01C4
EMDN: W0106010109
EMDN description: SICKLE CELL ANEMIA
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 23.07.2026 00:50

Manufacturer products Authorised representative products Authorised representative actors View details

SALSA MLPA Probemix P056 TP53

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211480799
Basic UDI-DI: 872021148P0565X
Reference: P056-025R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 21.07.2026 23:16

Manufacturer products View details

SALSA MLPA Probemix P056 TP53

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211480805
Basic UDI-DI: 872021148P0565X
Reference: P056-050R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 21.07.2026 22:51

Manufacturer products View details

SALSA MLPA Probemix P056 TP53

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211480812
Basic UDI-DI: 872021148P0565X
Reference: P056-100R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 21.07.2026 22:51

Manufacturer products View details

SALSA MLPA Probemix P062 LDLR

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211480850
Basic UDI-DI: 872021148P0625S
Reference: P062-025R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 17.07.2026 22:56

Manufacturer products View details

SALSA MLPA Probemix P045 BRCA2/CHEK2

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211480614
Basic UDI-DI: 872021148P0455S
Reference: P045-025R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 17.07.2026 22:56

Manufacturer products View details

SALSA MLPA Probemix P045 BRCA2/CHEK2

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211480621
Basic UDI-DI: 872021148P0455S
Reference: P045-050R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 22:39

Manufacturer products View details

SALSA MLPA Probemix P045 BRCA2/CHEK2

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211480638
Basic UDI-DI: 872021148P0455S
Reference: P045-100R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 22:39

Manufacturer products View details

SALSA MLPA Probemix P062 LDLR

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211480867
Basic UDI-DI: 872021148P0625S
Reference: P062-050R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 22:39

Manufacturer products View details