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785 device results listed.

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Leber Hereditary Optic Neuropathy Mitochondria Gene Testing Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle useSterile

Manufacturer: PSI Gene Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023276
UDI-DI: 16975843690057
Basic UDI-DI: B-16975843690057
Reference: 24 tests/kit
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 10:09

Manufacturer products Authorised representative products Authorised representative actors View details

Leber Hereditary Optic Neuropathy Mitochondria Gene Testing Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle useSterile

Manufacturer: PSI Gene Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023276
UDI-DI: 16975843690040
Basic UDI-DI: B-16975843690040
Reference: 12 tests/kit
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 10:09

Manufacturer products Authorised representative products Authorised representative actors View details

Corneal Dystrophy TGFBI Gene Testing Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle useSterile

Manufacturer: PSI Gene Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023276
UDI-DI: 16975843690033
Basic UDI-DI: B-16975843690033
Reference: 48 tests/kit
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 10:09

Manufacturer products Authorised representative products Authorised representative actors View details

Corneal Dystrophy TGFBI Gene Testing Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle useSterile

Manufacturer: PSI Gene Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023276
UDI-DI: 16975843690026
Basic UDI-DI: B-16975843690026
Reference: 24 tests/kit
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 10:09

Manufacturer products Authorised representative products Authorised representative actors View details

Corneal Dystrophy TGFBI Gene Testing Kit（Fluorescence PCR）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle useSterile

Manufacturer: PSI Gene Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023276
UDI-DI: 16975843690019
Basic UDI-DI: B-16975843690019
Reference: 12 tests/kit
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 10:09

Manufacturer products Authorised representative products Authorised representative actors View details

D-10106010104029X2

FMR1 CGG PCR

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Healthgene Laboratory Co.,Ltd
Manufacturer SRN: CN-MF-000032465
UDI-DI: D-10106010104029X2
Basic UDI-DI: B-10106010104029X2
Reference: 100 Tests/Kit
EMDN: W0106010104
EMDN description: FRAGILE X SYNDROME
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Synthetic Positive Controls for Haemochromatosis

Synthetic Positive Controls for Haemochromatosis

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044003547
Basic UDI-DI: B-09343044003547
Reference: 91171
EMDN: W0106010105
EMDN description: HAEMOCHROMATOSIS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Haemochromatosis 8-well

Step 1 Tubes for Haemochromatosis 8-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002335
Basic UDI-DI: B-09343044002335
Reference: 23156S
EMDN: W0106010105
EMDN description: HAEMOCHROMATOSIS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

Haemochromatosis 8-well

Step 2 Plates for Haemochromatosis 8-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002328
Basic UDI-DI: B-09343044002328
Reference: 23156P
EMDN: W0106010105
EMDN description: HAEMOCHROMATOSIS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat HLA-B27

601380025

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908020139507
Basic UDI-DI: B-08908020139507
Reference: 601380025
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat HLA-B27

601380050

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989842
Basic UDI-DI: B-08908007989842
Reference: 601380050
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat HLA-B27

601380020

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989835
Basic UDI-DI: B-08908007989835
Reference: 601380020
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat HLA-B27

601380005

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989828
Basic UDI-DI: B-08908007989828
Reference: 601380005, 601380020, 601380025, 601380050
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

Anyplex™ II Thrombosis SNP Panel Assay

Anyplex™ II Thrombosis SNP Panel Assay

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103906
Basic UDI-DI: B-08809240103906
Reference: TS10390Z
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:46

Manufacturer products Authorised representative products Authorised representative actors View details

Anyplex™ II Thrombosis SNP Panel Assay

Anyplex™ II Thrombosis SNP Panel Assay

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240100417
Basic UDI-DI: B-08809240100417
Reference: TS7600X
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Anyplex™ II Thrombosis SNP Panel Assay

Anyplex™ II Thrombosis SNP Panel Assay

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240100400
Basic UDI-DI: B-08809240100400
Reference: TS7600Y
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

GeneFinder HLA-ABCDRB1DQ RealAmp kit

IFMR-20

IVD Annex II List BIVDDOn the marketKitProfessional testingReagent

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115907356
Basic UDI-DI: B-08809115907356
Reference: IFMR-20.02B006-ABI
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 12:00

Manufacturer products Authorised representative products Authorised representative actors View details

GeneFinder HLA-ABCDRB1DQ RealAmp kit

IFMR-20

IVD Annex II List BIVDDOn the marketKitProfessional testingReagent

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115907349
Basic UDI-DI: B-08809115907349
Reference: IFMR-20.02B006-ABF
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 12:00

Manufacturer products Authorised representative products Authorised representative actors View details

GeneFinder HLA-ABCDRB1DQ RealAmp kit

IFMR-20

IVD Annex II List BIVDDOn the marketKitProfessional testingReagentSterile

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115904355
Basic UDI-DI: B-08809115904355
Reference: IFMR-20.02B006-CFX
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:58

Manufacturer products Authorised representative products Authorised representative actors View details

GeneFinder HLA-B*57:01 RealAmp Kit

IFMR-22

IVD Annex II List BIVDDOn the marketKitProfessional testingReagent

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115904324
Basic UDI-DI: B-08809115904324
Reference: IFMR-22.02B050
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Portugal
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details