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224 device results listed.

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SALSA MLPA Probemix P260 PALB2-RAD50-RAD51C-RAD51D

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211482113
Basic UDI-DI: 872021148P2605Y
Reference: P260-100R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 22:54

Manufacturer products View details

Genetic Deafness Gene Testing Kit (Multicolor Melting Curve Analysis)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Yaneng BIOscience (Shenzhen) Co., Ltd.
Manufacturer SRN: CN-MF-000013666
UDI-DI: 06955931305172
Basic UDI-DI: B-06955931305172
Reference: 213401
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Genetic Deafness Gene Testing Kit (Multicolor Melting Curve Analysis)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Yaneng BIOscience (Shenzhen) Co., Ltd.
Manufacturer SRN: CN-MF-000013666
UDI-DI: 06955931305165
Basic UDI-DI: B-06955931305165
Reference: 213401
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Spinal Muscular Atrophy Genetic Testing Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Yaneng BIOscience (Shenzhen) Co., Ltd.
Manufacturer SRN: CN-MF-000013666
UDI-DI: 06955931303031
Basic UDI-DI: B-06955931303031
Reference: 211701
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Spinal Muscular Atrophy Genetic Testing Kit（PCR-Fluorescence Probing）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Yaneng BIOscience (Shenzhen) Co., Ltd.
Manufacturer SRN: CN-MF-000013666
UDI-DI: 06955931303024
Basic UDI-DI: B-06955931303024
Reference: 211701
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735767

Human EGFR Gene E746_A750 Deletion Mutation Detection Kit (Digital PCR)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735767
Basic UDI-DI: B-06955792735767
Reference: S3290E-24
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735750

Human EGFR Gene L858R Mutation Detection Kit (Digital PCR)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735750
Basic UDI-DI: B-06955792735750
Reference: S3289E-24
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors View details

Carbapenemase Gene KPC Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732445
Basic UDI-DI: B-06955792732445
Reference: S3079E
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732452

Carbapenemase Gene KPC Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732452
Basic UDI-DI: B-06955792732452
Reference: S3079E
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

06942221701165

6 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Chaozhou Hybribio Biochemistry Ltd.
Manufacturer SRN: CN-MF-000023818
UDI-DI: 06942221701165
Basic UDI-DI: B-06942221701165
Reference: HBGA-G6PD
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

06942221701158

30 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Chaozhou Hybribio Biochemistry Ltd.
Manufacturer SRN: CN-MF-000023818
UDI-DI: 06942221701158
Basic UDI-DI: B-06942221701158
Reference: HBGA-G6PD
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

VitaSIRO solo MT-RNR1 SNP Assay

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570602
Basic UDI-DI: B-04719878570602
Reference: PCRAD1115
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

LAMP Human Lactose Intolerance Duplex KIT

LC-LacIDuplex-LP-24

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471532
Basic UDI-DI: B-05430002471532
Reference: LC-LacIDuplex-LP-24
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:50

Manufacturer products View details

LAMP Human PAI-1 mutation KIT

LC-PAI1-LP

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471419
Basic UDI-DI: B-05430002471419
Reference: LC-PAI1-LP-24
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:50

Manufacturer products View details

LAMP Human Lactose Intolerance Duplex KIT

LC-LacIDuplex-LP-96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471211
Basic UDI-DI: B-05430002471211
Reference: LC-LacIDuplex-LP-96
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:50

Manufacturer products View details

LAMP Human MTHFR 2nd mutation KIT (rs1801131)

LC-2ndMTHFR-LP-96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471136
Basic UDI-DI: B-05430002471136
Reference: LC-2ndMTHFR-LP-96
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:49

Manufacturer products View details

LAMP Human MTHFR 2nd mutation KIT (rs1801131)

LC-2ndMTHFR-LP

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471129
Basic UDI-DI: B-05430002471129
Reference: LC-2ndMTHFR-LP-24
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:49

Manufacturer products View details

LAMP Human Lactose Intolerance KIT

LC-LacI-LP-96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471112
Basic UDI-DI: B-05430002471112
Reference: LC-LacI-LP-96
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:49

Manufacturer products View details

LAMP Human Lactose Intolerance KIT

LC-LacI-LP

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471105
Basic UDI-DI: B-05430002471105
Reference: LC-LacI-LP-24
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:49

Manufacturer products View details

LAMP Human MTHFR mutation KIT (rs1801133)

LC-MTHFR-LP-96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471051
Basic UDI-DI: B-05430002471051
Reference: LC-MTHFR-LP-96
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:49

Manufacturer products View details