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141 device results listed.

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geneMAP

geneMAP FMF 11 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-TRMF000028405FMFRT50HM
Basic UDI-DI: B-TRMF000028405FMFRT50HM
Reference: FMF-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

geneMAP

geneMAP FMF 5 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-TRMF000028405FMF5RT506T
Basic UDI-DI: B-TRMF000028405FMF5RT506T
Reference: FMF.5-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

Survival Motor Neuron 1 (SMN1) Gene Detection Real Time PCR Kit

IVD generalNot specifiedOn the market

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JGM10201NW-50TH4
Basic UDI-DI: B-JGM10201NW-50TH4
Reference: JGM10201NW-50T
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:24

Manufacturer products Authorised representative products Authorised representative actors View details

Survival Motor Neuron 1 (SMN1) Gene Detection Real Time PCR Kit

IVD generalNot specifiedOn the market

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JGM10201NW-25TH4
Basic UDI-DI: B-JGM10201NW-25TH4
Reference: JGM10201NW-25T
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:24

Manufacturer products Authorised representative products Authorised representative actors View details

Human Survival Motor Neuron(SMN)Gene Detection Kit (Digital PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Biorain biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000049232
UDI-DI: D-CNMF000049232R3300196W9
Basic UDI-DI: B-CNMF000049232R3300196W9
Reference: R33001-096
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:07

Manufacturer products Authorised representative products Authorised representative actors View details

Human Survival Motor Neuron(SMN)Gene Detection Kit (Digital PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Biorain biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000049232
UDI-DI: D-CNMF000049232R3300148VW
Basic UDI-DI: B-CNMF000049232R3300148VW
Reference: R33001-048
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-9021B6

Partner and Localiser of BRCA2 (PALB2) Library Prep Kit for Illumina®

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: NimaGen BV
Manufacturer SRN: NL-MF-000022926
UDI-DI: D-9021B6
Basic UDI-DI: B-9021B6
Reference: RC-PALB096-I
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:55

Manufacturer products View details

IntRaFast-Q SMA SCREENING KIT

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: SNP BİYOTEKNOLOJİ ARAŞTIRMA GELİŞTİRME VE ÜRETİM SANAYİ VE TİCARET LİMİTED ŞİRKETİLİMİTED
Manufacturer SRN: TR-MF-000036548
UDI-DI: D-86804222814035R
Basic UDI-DI: B-86804222814035R
Reference: 200R-40-01
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 12.07.2026 11:18

Manufacturer products View details

YChromStrip

3.151.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295773151WMFN
Basic UDI-DI: B-84295773151WMFN
Reference: 3.151.XXX.YY.ZZZ
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

Anyplex™ II Thrombosis SNP Panel Assay

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103906
Basic UDI-DI: B-08809240103906
Reference: TS10390Z
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:46

Manufacturer products Authorised representative products Authorised representative actors View details

Anyplex™ II Thrombosis SNP Panel Assay

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240100417
Basic UDI-DI: B-08809240100417
Reference: TS7600X
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Anyplex™ II Thrombosis SNP Panel Assay

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240100400
Basic UDI-DI: B-08809240100400
Reference: TS7600Y
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

TaqPath™ Menu | GeneProof™ Factor XIII V34L PCR Kit

GeneProof Factor XIII V34L PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696304294
Basic UDI-DI: B-08595696304294
Reference: A58422
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:59

Manufacturer products View details

GeneProof Factor XIII V34L MC PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696302696
Basic UDI-DI: B-08595696302696
Reference: FXIII/MC/040
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:58

Manufacturer products View details

GeneProof Factor XIII V34L PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161959915
Basic UDI-DI: B-08594161959915
Reference: FXIII/100
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:49

Manufacturer products View details

GeneProof Factor XIII V34L MC PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161958529
Basic UDI-DI: B-08594161958529
Reference: FXIII/MC/200
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:49

Manufacturer products View details

GeneProof Factor XIII V34L PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161956983
Basic UDI-DI: B-08594161956983
Reference: FXIII/025
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:49

Manufacturer products View details

Adellgene® Myotonic Dystrophy Screening 16 tests

Adellgene® Myotonic Dystrophy Screening

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942338
Basic UDI-DI: B-08437016942338
Reference: AD-MD-16
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:53

Manufacturer products View details

Inherited CardioKitDx

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Health in Code, S.L.
Manufacturer SRN: ES-MF-000054848
UDI-DI: 08436589881853
Basic UDI-DI: B-08436589881853
Reference: IMG-390
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:50

Manufacturer products View details

08057723370615

SMART SNP MTHFR 1298 Positive Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370615
Basic UDI-DI: B-08057723370615
Reference: SNPD-032 CTRL
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:37

Manufacturer products View details