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229 device results listed.

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Human SLCO1B1 Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733312
Basic UDI-DI: B-06955792733312
Reference: S3087E
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

Human CYP2C9 and VKORC1 Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733305
Basic UDI-DI: B-06955792733305
Reference: S3088E
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitMicrobial substancesProfessional testing

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733299
Basic UDI-DI: B-06955792733299
Reference: S3086E
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD generalIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733282
Basic UDI-DI: B-06955792733282
Reference: S3085E
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD generalIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733275
Basic UDI-DI: B-06955792733275
Reference: S3089E
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

Human CYP2C19 Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733251
Basic UDI-DI: B-06955792733251
Reference: S3084E
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

LAMP Human HLA Coeliac direct KIT

LC-HLACD-LP-96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471273
Basic UDI-DI: B-05430002471273
Reference: LC-HLACD-LP-96
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:50

Manufacturer products View details

LAMP Human HLA Coeliac direct KIT

LC-HLACD-LP-24

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471266
Basic UDI-DI: B-05430002471266
Reference: LC-HLACD-LP-24
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:50

Manufacturer products View details

LAMP Human HLA-B27 direct detection KIT

LC-HLAB27Direct-LP-96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471259
Basic UDI-DI: B-05430002471259
Reference: LC-HLAB27Direct-LP-96
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:50

Manufacturer products View details

LAMP Human HLA-B27 direct detection KIT

LC-HLAB27Direct-LP-24

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471242
Basic UDI-DI: B-05430002471242
Reference: LC-HLAB27Direct-LP-24
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:50

Manufacturer products View details

LAMP Human CYP2C9 deficiency KIT

LC-CYP2C9-LP

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471228
Basic UDI-DI: B-05430002471228
Reference: LC-CYP2C9-LP-24
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:50

Manufacturer products View details

LAMP Human HLA-B27 detection KIT

LC-HLAB27-LP-96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471198
Basic UDI-DI: B-05430002471198
Reference: LC-HLAB27-LP-96
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:50

Manufacturer products View details

05430002471181

LC-HLAB27-LP-24

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471181
Basic UDI-DI: B-05430002471181
Reference: LC-HLAB27-LP-24
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:49

Manufacturer products View details

LAMP Human DPD deficiency KIT - 4 mutations

IVD generalNot specifiedOn the market

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471167
Basic UDI-DI: B-05430002471167
Reference: LC-DPD4mut-LP-96
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:49

Manufacturer products View details

LAMP Human DPD deficiency KIT - 4 mutations

IVD generalNot specifiedOn the market

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471150
Basic UDI-DI: B-05430002471150
Reference: LC-DPD4mut-LP-24
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:49

Manufacturer products View details

05430002471143

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: 02.08.2026 21:49

Manufacturer products View details

FetoGnost® Kit RHD

IVD Class DIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Ingenetix GmbH
Manufacturer SRN: AT-MF-000001501
UDI-DI: 09120110505897
Basic UDI-DI: 912011050HUFGRXX8D
Reference: HUFG100
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Austria
Safety summary (SSCP/SSP): FB257_V04 · Rev. 3.0
Authorised representative: -
Last updated: 01.08.2026 00:39

Manufacturer products Open in EUDAMED View details

gb GENETIC A1AT

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

Manufacturer: GENERI BIOTECH s.r.o.
Manufacturer SRN: CZ-MF-000018857
UDI-DI: 08595223925114
Basic UDI-DI: 85952239000001WU
Reference: 3251-025
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 31.07.2026 23:17

Manufacturer products View details

04260224890580

FastQ® B*27 direct

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testing

Manufacturer: BAG Diagnostics GmbH
Manufacturer SRN: DE-MF-000024383
UDI-DI: 04260224890580
Basic UDI-DI: 426022489FAQD01ACAS
Reference: 728201
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:44

Manufacturer products View details

geneMAP

geneMAP DPYD Mutations Detection Kit, 25T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405DPYDRT25KS
Basic UDI-DI: B-TRMF000028405DPYDRT25KS
Reference: DPYD-RT25
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:20

Manufacturer products View details