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309 device results listed.

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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: 08595223925121
Basic UDI-DI: 85952239000001WU
Reference: 3251-050
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 04.08.2026 22:43

Manufacturer products View details

D-90092-RTF4

EliGene® Lactose intolerance RT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ELISABETH PHARMACON, spol. s r.o.
Manufacturer SRN: CZ-MF-000025244
UDI-DI: D-90092-RTF4
Basic UDI-DI: B-90092-RTF4
Reference: 90092-RT
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 04.08.2026 19:28

Manufacturer products View details

D-90060-C6AE

EliGene® Spondylitis HLA-B27 C6

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ELISABETH PHARMACON, spol. s r.o.
Manufacturer SRN: CZ-MF-000025244
UDI-DI: D-90060-C6AE
Basic UDI-DI: B-90060-C6AE
Reference: 90060-C6
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Czechia
Authorised representative: -
Last updated: 04.08.2026 19:28

Manufacturer products View details

06955792735743

Human ALDH2 and ADH1B Genetic Polymorphism Nucleic Acid Detection Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735743
Basic UDI-DI: B-06955792735743
Reference: S3212E-24
EMDN: W0106010499
EMDN description: POLYMORPHISM 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

Human TPMT Genetic Polymorphism Nucleic Acid Detection Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733718
Basic UDI-DI: B-06955792733718
Reference: S3211E-24
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:01

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD generalNot specifiedOn the market

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733381
Basic UDI-DI: B-06955792733381
Reference: S3098E
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD generalIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733374
Basic UDI-DI: B-06955792733374
Reference: S3098E
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 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