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445 device results listed.

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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

D-9018BH

Cystic Fibrosis Transmembrane Conductance Regulator Gene (CFTR) Library Prep Kit for Illumina®

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: NimaGen BV
Manufacturer SRN: NL-MF-000022926
UDI-DI: D-9018BH
Basic UDI-DI: B-9018BH
Reference: RC-CFTR096-I
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:55

Manufacturer products View details

D-9017BF

Cystic Fibrosis Transmembrane Conductance Regulator Gene (CFTR) Mutation Hotspots Library Prep Kit for Illumina®

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: NimaGen BV
Manufacturer SRN: NL-MF-000022926
UDI-DI: D-9017BF
Basic UDI-DI: B-9017BF
Reference: RC-CFHS096-I
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:54

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

HemochromaStrip

3.130.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295773130WDEH
Basic UDI-DI: B-84295773130WDEH
Reference: 3.130.XXX.YY.ZZZ
EMDN: W0106010105
EMDN description: HAEMOCHROMATOSIS
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

ThromboSrip

3.117.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295773117WMFQ
Basic UDI-DI: B-84295773117WMFQ
Reference: 3.117.XXX.YY.ZZZ
EMDN: W0106010115
EMDN description: COMBINED FACTOR II / FACTOR V LEIDEN
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

D-10106010104029X2

FMR1 CGG PCR

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Healthgene Laboratory Co.,Ltd
Manufacturer SRN: CN-MF-000032465
UDI-DI: D-10106010104029X2
Basic UDI-DI: B-10106010104029X2
Reference: 100 Tests/Kit
EMDN: W0106010104
EMDN description: FRAGILE X SYNDROME
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Synthetic Positive Controls for Haemochromatosis

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044003547
Basic UDI-DI: B-09343044003547
Reference: 91171
EMDN: W0106010105
EMDN description: HAEMOCHROMATOSIS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Haemochromatosis 8-well

Step 1 Tubes for Haemochromatosis 8-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002335
Basic UDI-DI: B-09343044002335
Reference: 23156S
EMDN: W0106010105
EMDN description: HAEMOCHROMATOSIS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

Haemochromatosis 8-well

Step 2 Plates for Haemochromatosis 8-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002328
Basic UDI-DI: B-09343044002328
Reference: 23156P
EMDN: W0106010105
EMDN description: HAEMOCHROMATOSIS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:42

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: 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

ChainFor Sickle Cell Disease Detection qPCR Kit

CFP92

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257895
Basic UDI-DI: B-08683548257895
Reference: CFP92
EMDN: W0106010109
EMDN description: SICKLE CELL ANEMIA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:17

Manufacturer products View details

RapidFor™ Sickle Cell Rapid Test Kit

VMD72

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548252036
Basic UDI-DI: B-08683548252036
Reference: VMD72
EMDN: W0106010109
EMDN description: SICKLE CELL ANEMIA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:13

Manufacturer products View details

TaqPath™ Menu | GeneProof™ MTHFR A1298C PCR Kit

GeneProof MTHFR A1298C PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696304324
Basic UDI-DI: B-08595696304324
Reference: A58425
EMDN: W0106010116
EMDN description: OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:59

Manufacturer products View details

TaqPath™ Menu | GeneProof™ MTHFR C677T PCR Kit

GeneProof MTHFR C677T PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696304317
Basic UDI-DI: B-08595696304317
Reference: A58424
EMDN: W0106010116
EMDN description: OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:59

Manufacturer products View details

TaqPath™ Menu | GeneProof™ PAI1 Genotyping PCR Kit

GeneProof PAI1 Genotyping PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696304300
Basic UDI-DI: B-08595696304300
Reference: A58423
EMDN: W0106010116
EMDN description: OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:59

Manufacturer products View details