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Vazyme Precision Max1 Dx Panel

NC313ME-C2

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06979469761729
Basic UDI-DI: 6979469761729NB
Reference: NC313ME-C2
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 24.07.2026 09:19

Manufacturer products Authorised representative products Authorised representative actors View details

Vazyme Precision 156 Dx Panel

NC310ME-C2

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06979469761712
Basic UDI-DI: 6979469761712MS
Reference: NC310ME-C2
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 24.07.2026 09:19

Manufacturer products Authorised representative products Authorised representative actors View details

KMRassay qPCR buffer & Enzyme

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: D-88432834G
Basic UDI-DI: B-88432834G
Reference: 8843283
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 24.07.2026 00:41

Manufacturer products View details

Idylla™ MSI Test

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Biocartis NV
Manufacturer SRN: BE-MF-000003661
UDI-DI: 15415219000550
Basic UDI-DI: B-15415219000550
Reference: A0100/6
EMDN: W01060214
EMDN description: COLORECTAL CANCER (MSI-H / DMMR)
First on market country: Belgium
Authorised representative: -
Last updated: 24.07.2026 00:36

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

NovaSeq™ 6000Dx Library Tubes, 24 Pk

NovaSeq™ 6000Dx Library Tube

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020583
Basic UDI-DI: 0081627002NSQTUBECX
Reference: 20062291
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 22.07.2026 03:18

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

D-A070D4

PHASIFY™ Endometrial Cancer Methylation Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A070D4
Basic UDI-DI: B-A070D4
Reference: PHASIFY™ Endometrial Cancer Methylation Test
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details