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769 device results listed.

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Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)

24 tests/kit (Pre-packaged)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584268
Basic UDI-DI: B-06974968584268
Reference: L000157-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

SALSA MLPA Probemix P015 MECP2

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211480263
Basic UDI-DI: 872021148P0155H
Reference: P015-050R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 12:39

Manufacturer products View details

gb GENETIC HFE

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: GENERI BIOTECH s.r.o.
Manufacturer SRN: CZ-MF-000018857
UDI-DI: 08595223920829
Basic UDI-DI: 85952239000005X4
Reference: 3208-050
EMDN: W0106010105
EMDN description: HAEMOCHROMATOSIS
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:32

Manufacturer products View details

gb GENETIC APOE

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: GENERI BIOTECH s.r.o.
Manufacturer SRN: CZ-MF-000018857
UDI-DI: 08595223920614
Basic UDI-DI: 85952239000003WY
Reference: 3206-025
EMDN: W0106010203
EMDN description: ATHEROSCLEROSIS
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:32

Manufacturer products View details

08033629924473

CF FAST

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629924473
Basic UDI-DI: 803362992GENSCREENKT
Reference: AA1358/48A
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 11:47

Manufacturer products View details

NIFTY®

96 tests

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05744003510238
Basic UDI-DI: 574400351MFG03011085
Reference: MFG030110, MFG030111, MFG030112
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: Denmark
Safety summary (SSCP/SSP): BGIEU-STP-CE-116-011 · Rev. 3
Authorised representative: -
Last updated: 16.07.2026 10:07

Manufacturer products Open in EUDAMED View details

CytoScan Dx Array, 6 pk

CytoScan Dx Assay, a part of CytoScan™ Dx Test

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Affymetrix, Inc.
Manufacturer SRN: US-MF-000028847
UDI-DI: 00856826006098
Basic UDI-DI: 0856826006902420G9
Reference: 902150 (902420)
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 16.07.2026 06:41

Manufacturer products Authorised representative products Authorised representative actors View details

AmplideX Fragile X Dx & Carrier Screen Kit

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingSingle use

Manufacturer: Asuragen, Inc.
Manufacturer SRN: US-MF-000011830
UDI-DI: 00850017493124
Basic UDI-DI: 0850017493A011248A
Reference: A01124
EMDN: W0106010104
EMDN description: FRAGILE X SYNDROME
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:15

Manufacturer products Authorised representative products Authorised representative actors View details

VeriSeq™ NIPT v2 Assay Software

VeriSeq™ NIPT Assay Software

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020194
Basic UDI-DI: 0081627002NIPTSWXJ
Reference: 20047024
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 15.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

VeriSeq™ NIPT Sample Preparation Kit (24 samples)

VeriSeq™ NIPT Sample Preparation Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020163
Basic UDI-DI: 0081627002NIPTRP
Reference: 20025895
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 15.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

TruSight™ Cystic Fibrosis Library Prep

TruSight™ Cystic Fibrosis

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020149
Basic UDI-DI: 0081627002CYSTFIB8C
Reference: 20036925
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 15.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

H-Seq-LR-NGS Sequenzierungskit für 48 Typisierungen

H-Seq-LR-NGS.m4 Ref 021

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH
Manufacturer SRN: DE-MF-000018980
UDI-DI: +G2860230Z
Basic UDI-DI: ++G286LongRangeNGS7K
Reference: 021
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 20:22

Manufacturer products View details

H-Seq-NGS Sequenzierungskit für 7x768 Typisierungen

H-Seq-NGS, Ref 014

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH
Manufacturer SRN: DE-MF-000018980
UDI-DI: +G2860140Z
Basic UDI-DI: ++G286HSeqNGSP9
Reference: 014
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 20:22

Manufacturer products View details

H-Seq-ABC Sequenzierungskit für 48 Typisierungen

H-Seq-ABC Ref 001

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH
Manufacturer SRN: DE-MF-000018980
UDI-DI: +G2860010V
Basic UDI-DI: ++G286HSeqABCKR
Reference: 001
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 20:22

Manufacturer products View details

Sickle SCAN Test

CXJ020

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: BioMedomics
Manufacturer SRN: US-MF-000054278
UDI-DI: D-USMF000054278BMCXJ020HP
Basic UDI-DI: B-USMF000054278BMCXJ020HP
Reference: CXJ020
EMDN: W0106010109
EMDN description: SICKLE CELL ANEMIA
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 13:09

Manufacturer products Authorised representative products Authorised representative actors View details

geneMAP

geneMAP FXIII Mutation Detection Kit, 50T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405THRRT50T6
Basic UDI-DI: B-TRMF000028405THRRT50T6
Reference: THR-RT50
EMDN: W0106010115
EMDN description: COMBINED FACTOR II / FACTOR V LEIDEN
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:23

Manufacturer products View details

geneMAP

geneMAP Thrombophilia P., 50T (FII, FVL,MTHFR677, MTHFR1298, PAI,FXIII)

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405THR6RT50HP
Basic UDI-DI: B-TRMF000028405THR6RT50HP
Reference: THR6-RT50
EMDN: W0106010115
EMDN description: COMBINED FACTOR II / FACTOR V LEIDEN
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:23

Manufacturer products View details

geneMAP

geneMAP SMN1 Exon7/8 Screening Kit, 50T

IVD generalIVDDOn the marketKit

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405SMN1MRT5J5
Basic UDI-DI: B-TRMF000028405SMN1MRT5J5
Reference: SMN1M-RT50
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:23

Manufacturer products View details

geneMAP

geneMAP PAI-1 4G/5G Mutation Detection Kit, 50T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405PAIRT50K4
Basic UDI-DI: B-TRMF000028405PAIRT50K4
Reference: PAI-RT50
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:23

Manufacturer products View details

geneMAP

geneMAP MTHFR C677T Mutation Detection Kit, 50T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405MTHFIRT5MU
Basic UDI-DI: B-TRMF000028405MTHFIRT5MU
Reference: MTHFI-RT50
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:22

Manufacturer products View details