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452 device results listed.

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LAMP Human Hemochromatosis KIT (rs1800562/rs1799945)

LC-HFE-LP-96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471075
Basic UDI-DI: B-05430002471075
Reference: LC-HFE-LP-96
EMDN: W0106010105
EMDN description: HAEMOCHROMATOSIS
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:49

Manufacturer products View details

LAMP Human Hemochromatosis KIT (rs1800562/rs1799945)

LC-HFE-LP

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471068
Basic UDI-DI: B-05430002471068
Reference: LC-HFE-LP-24
EMDN: W0106010105
EMDN description: HAEMOCHROMATOSIS
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

LAMP Human MTHFR mutation KIT (rs1801133)

LC-MTHFR-LP

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471044
Basic UDI-DI: B-05430002471044
Reference: LC-MTHFR-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 FV LEIDEN KIT (rs6025)

LC-FVL-LP-96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471037
Basic UDI-DI: B-05430002471037
Reference: LC-FVL-LP-96
EMDN: W0106010103
EMDN description: FACTOR V LEIDEN
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:49

Manufacturer products View details

LAMP Human FV LEIDEN KIT (rs6025)

LC-FVL-LP

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471020
Basic UDI-DI: B-05430002471020
Reference: LC-FVL-LP-24
EMDN: W0106010103
EMDN description: FACTOR V LEIDEN
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:49

Manufacturer products View details

LAMP Human Prothrombin mutation KIT (rs1799963)

LC-FII-LP-96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471013
Basic UDI-DI: B-05430002471013
Reference: LC-FII-LP-96
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:49

Manufacturer products View details

LAMP Human Prothrombin mutation KIT (rs1799963)

LC-FII-LP

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471006
Basic UDI-DI: B-05430002471006
Reference: LC-FII-LP-24
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:49

Manufacturer products View details

ZENA MAX Factor V R2 Polymorphism Real Time PCR Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Advanced Molecular Diagnostics Ltd
Manufacturer SRN: UK-MF-000043044
UDI-DI: 05061059980298
Basic UDI-DI: B-05061059980298
Reference: KD6466232-100
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 02.08.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

ZENA MAX Janus Kinase 2 (JAK2) V617F Real Time PCR Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Advanced Molecular Diagnostics Ltd
Manufacturer SRN: UK-MF-000043044
UDI-DI: 05061059980250
Basic UDI-DI: B-05061059980250
Reference: KD6466182-100
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 02.08.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

ZENA MAX MTHFR (A1298C) Real Time PCR Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Advanced Molecular Diagnostics Ltd
Manufacturer SRN: UK-MF-000043044
UDI-DI: 05061059980243
Basic UDI-DI: B-05061059980243
Reference: KD6466352-100
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 02.08.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

ZENA MAX MTHFR C677T Real Time PCR Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Advanced Molecular Diagnostics Ltd
Manufacturer SRN: UK-MF-000043044
UDI-DI: 05061059980236
Basic UDI-DI: B-05061059980236
Reference: KD6466372-100
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 02.08.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

ZENA MAX Human Factor V Leiden (FVL) Real Time PCR Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Advanced Molecular Diagnostics Ltd
Manufacturer SRN: UK-MF-000043044
UDI-DI: 05061059980205
Basic UDI-DI: B-05061059980205
Reference: KD187648-100
EMDN: W0106010103
EMDN description: FACTOR V LEIDEN
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 02.08.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

ZENA MAX Human Factor II Prothrombin “20210 Mutation” Real Time PCR Kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Advanced Molecular Diagnostics Ltd
Manufacturer SRN: UK-MF-000043044
UDI-DI: 05061059980199
Basic UDI-DI: B-05061059980199
Reference: KD184567-100
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 02.08.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)

Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173657006
Basic UDI-DI: B-00810173657006
Reference: N7001D
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)

Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656993
Basic UDI-DI: B-00810173656993
Reference: N7001C
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Yourgene® Cystic Fibrosis Base

Yourgene® Cystic Fibrosis

IVD Class CIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Yourgene Health UK Ltd
Manufacturer SRN: GB-MF-000024810
UDI-DI: 05060402680007
Basic UDI-DI: 506040268CFLR
Reference: CF2EUB2
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: France
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:43

Manufacturer products Authorised representative products Authorised representative actors View details

SALSA MLPA Probemix P102 HBB

D1

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211481376
Basic UDI-DI: 872021148P1025D
Reference: P102-025R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 28.07.2026 01:23

Manufacturer products View details

SALSA MLPA Probemix P102 HBB

-

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211481383
Basic UDI-DI: 872021148P1025D
Reference: P102-050R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 27.07.2026 22:57

Manufacturer products View details

SALSA MLPA Probemix P102 HBB

-

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211481390
Basic UDI-DI: 872021148P1025D
Reference: P102-100R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 27.07.2026 22:57

Manufacturer products View details