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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

Genvinset® HLA B51

Genvinset® HLA B51 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: 08436615250097
Basic UDI-DI: 843661525GVS-B51N4
Reference: GVS-B51-24
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 22:55

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

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: 08720211480874
Basic UDI-DI: 872021148P0625S
Reference: P062-100R
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

Genvinset® HLA B51 48 test

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08436615250103
Basic UDI-DI: 843661525GVS-B51N4
Reference: GVS-B51-48
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 22:37

Manufacturer products View details

Xpert®

Xpert® NPM1 Mutation

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940008390
Basic UDI-DI: B-07332940008390
Reference: GXNPM1-CE-10
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert®

Xpert® FII & FV

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940000240
Basic UDI-DI: B-07332940000240
Reference: GXFIIFV-10
EMDN: W0106010115
EMDN description: COMBINED FACTOR II / FACTOR V LEIDEN
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)

384 tests/kit (Pre-packaged)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584312
Basic UDI-DI: B-06974968584312
Reference: L000162-P
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 19:13

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)

96 tests/kit (Pre-packaged)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584305
Basic UDI-DI: B-06974968584305
Reference: L000161-P
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 19:13

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)

64 tests/kit (Pre-packaged)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584299
Basic UDI-DI: B-06974968584299
Reference: L000160-P
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 19:13

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)

48tests/kit (Pre-packaged)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584282
Basic UDI-DI: B-06974968584282
Reference: L000159-P
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 19:13

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)

32 tests/kit (Pre-packaged)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584275
Basic UDI-DI: B-06974968584275
Reference: L000158-P
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 19:13

Manufacturer products Authorised representative products Authorised representative actors View details