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NEONATAL SCID&SMA Screening qPCR FLEX

LC-SCID&SMA-QPCR-FLEX

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430003908334
Basic UDI-DI: 5430003908SCIDSMAFlexX7
Reference: LC-SCID&SMA-QPCR-FLEX-480
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 24.09.2026 04:45

Manufacturer products View details

MutaPLATE® VDR BsmI Real-Time-PCR-Kit

MutaPLATE® VDR3/Bsm1 ™, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598002241
Basic UDI-DI: B-04050598002241
Reference: KF1900432
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 01:30

Manufacturer products View details

MutaPLATE® VDR BsmI Real-Time-PCR-Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598002258
Basic UDI-DI: B-04050598002258
Reference: KF1900496
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 01:30

Manufacturer products View details

MutaPLATE® HLA-DQ 2+8 (TM) PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598003507
Basic UDI-DI: B-04050598003507
Reference: KF190532+
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 00:19

Manufacturer products View details

Targeted qPCR SMA

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430003908266
Basic UDI-DI: 5430002471K-LT-FU
Reference: K-LT-480H
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 23:09

Manufacturer products View details

Lamp Human TPMT deficiency KIT

LC-TPMT-LP

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471143
Basic UDI-DI: B-05430002471143
Reference: LC-TPMT-LP-24
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 23.09.2026 20:28

Manufacturer products View details

SALSA MLPA Probemix P405 CMT1

SALSA MLPA Probemix P405 CMT1A/CMT1X/HNPP

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211482274
Basic UDI-DI: 872021148P40562
Reference: P405-025R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 23.09.2026 14:33

Manufacturer products View details

Genvinset® HLA B51 24 test

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08436615250097
Basic UDI-DI: 843661525GVS-B51N4
Reference: GVS-B51-24
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Spain
Authorised representative: -
Last updated: 22.09.2026 21:04

Manufacturer products View details

06955792743434

Human ALDH2 Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing)

IVD generalIVDDNo longer on the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743434
Basic UDI-DI: B-06955792743434
Reference: S3351E-24-P
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 22.09.2026 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

SALSA MLPA Probemix P405 CMT1

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211482281
Basic UDI-DI: 872021148P40562
Reference: P405-050R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 23:28

Manufacturer products View details

SALSA MLPA Probemix P405 CMT1

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211482298
Basic UDI-DI: 872021148P40562
Reference: P405-100R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 23:28

Manufacturer products View details

SALSA MLPA Probemix P405 CMT1A/CMT1X/HNPP

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211482786
Basic UDI-DI: 872021148P40562
Reference: P405-025R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 23:28

Manufacturer products View details

SALSA MLPA Probemix P405 CMT1A/CMT1X/HNPP

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211482793
Basic UDI-DI: 872021148P40562
Reference: P405-050R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 23:28

Manufacturer products View details

SALSA MLPA Probemix P405 CMT1A/CMT1X/HNPP

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211482809
Basic UDI-DI: 872021148P40562
Reference: P405-100R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 23:28

Manufacturer products View details

04049095161100

RIDA®GENE Lac Intol

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095161100
Basic UDI-DI: B-04049095161100
Reference: PY4215
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 23:23

Manufacturer products View details

SALSA MLPA Probemix P101 STK11

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211481345
Basic UDI-DI: 872021148P1015B
Reference: P101-025R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 21.09.2026 22:20

Manufacturer products View details

LAMP Human CYP2C19 deficiency KIT

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430003908457
Basic UDI-DI: 5430002471LC-CYP2C19-LPUV
Reference: LC-CYP2C19-LP-96
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 22:16

Manufacturer products View details

LAMP Human DPD Deficiency KIT (5 variants)

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430003908402
Basic UDI-DI: 5430003908DPD5var9P
Reference: LC-DPD5var-LP-96
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 22:14

Manufacturer products View details

LAMP Human DPD Deficiency KIT (4 variants)

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430003908396
Basic UDI-DI: 5430003908DPD4var9G
Reference: LC-DPD4var-LP-96
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 22:14

Manufacturer products View details

NEONATAL SCID&SMA Screening qPCR FLEX

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430003908495
Basic UDI-DI: 5430003908SCIDSMAFlexX7
Reference: LC-SCID&SMA-QPCR-FLEX-480H
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 22:14

Manufacturer products View details