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Detection Kit for Human MTHFR Gene Polymorphism (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870781
Basic UDI-DI: B-06974081870781
Reference: MTHFR
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:44

Manufacturer products Authorised representative products Authorised representative actors View details

K019-FactorV / Prothrombin

K019-Factor V / Prothrombin

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430409
Basic UDI-DI: B-04262420430409
Reference: K019
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:44

Manufacturer products View details

HPA-FluoGene 1a/b Screen

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152483830
Basic UDI-DI: B-04260152483830
Reference: 003 011 048
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details

RBC-FluoGene ABO basic

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152483779
Basic UDI-DI: B-04260152483779
Reference: 001 086 010
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details

HPA-FluoGene NX

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152483458
Basic UDI-DI: B-04260152483458
Reference: 003 015 048
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details

HPA-FluoGene NX

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152483441
Basic UDI-DI: B-04260152483441
Reference: 003 015 010
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details

HLA-Ready Gene B27

HLA Ready Gene B27

IVD Annex II List BIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152483168
Basic UDI-DI: B-04260152483168
Reference: 002058096
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details

HLA-Ready Gene B57

IVD Annex II List BIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152483137
Basic UDI-DI: B-04260152483137
Reference: 002 062 032
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details

HLA-Ready Gene Coeliac Disease

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152483120
Basic UDI-DI: B-04260152483120
Reference: 002 061 032
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details

RBC-Ready Gene ABO

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152480013
Basic UDI-DI: B-04260152480013
Reference: 001 010 012
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details

HLA-Ready Gene B27

IVD Annex II List BIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152483090
Basic UDI-DI: B-04260152483090
Reference: 002 058 032
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details

Pathogen Multiplex-PCR Library Prep Kit

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Health SwifTech Co., Ltd.
Manufacturer SRN: CN-MF-000044339
UDI-DI: 06977805760160
Basic UDI-DI: 697780576HSTAALIBGD7
Reference: AA03-01-96D
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

SALSA MLPA Probemix P081 NF1 mix 1

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211481062
Basic UDI-DI: 872021148P0815W
Reference: P081-025R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 04.08.2026 22:57

Manufacturer products View details

gb PHARM Warfarin

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: GENERI BIOTECH s.r.o.
Manufacturer SRN: CZ-MF-000018857
UDI-DI: 08595223925015
Basic UDI-DI: 85952239000019XF
Reference: 3250-025
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 04.08.2026 22:56

Manufacturer products View details

gb PHARM Warfarin

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: GENERI BIOTECH s.r.o.
Manufacturer SRN: CZ-MF-000018857
UDI-DI: 08595223925022
Basic UDI-DI: 85952239000019XF
Reference: 3250-050
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 04.08.2026 22:56

Manufacturer products View details

Pathogen Multiplex-PCR Library Prep Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Shenzhen Health SwifTech Co., Ltd.
Manufacturer SRN: CN-MF-000044339
UDI-DI: 06977805760306
Basic UDI-DI: 697780576HSTAALIBGD7
Reference: AA03-01-96D
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

SALSA MLPA Probemix P081 NF1 mix 1

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211481079
Basic UDI-DI: 872021148P0815W
Reference: P081-050R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 04.08.2026 22:51

Manufacturer products View details

SALSA MLPA Probemix P081 NF1 mix 1

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211481086
Basic UDI-DI: 872021148P0815W
Reference: P081-100R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 04.08.2026 22:51

Manufacturer products View details

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: 08720211482090
Basic UDI-DI: 872021148P2605Y
Reference: P260-025R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 04.08.2026 22:46

Manufacturer products View details

SALSA MLPA Probemix P155 EDS

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211481567
Basic UDI-DI: 872021148P15562
Reference: P155-050R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 04.08.2026 22:46

Manufacturer products View details