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218 device results listed.

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DECOCENT

IVD Class AIVDR 2017/746On the marketKitReagentSingle use

Manufacturer: DIAGNOTIS SAS
Manufacturer SRN: FR-MF-000035861
UDI-DI: 03770032939032
Basic UDI-DI: 3770032939DCC051S6
Reference: DCC051
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:14

Manufacturer products View details

MYCOPROSAFE

IVD Class AIVDR 2017/746On the marketDirect markingKitReagentSingle use

Manufacturer: DIAGNOTIS SAS
Manufacturer SRN: FR-MF-000035861
UDI-DI: 03770032939001
Basic UDI-DI: 3770032939TM240Y5
Reference: TM240
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:13

Manufacturer products View details

ichroma™ IGRA-TB

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133045251
Basic UDI-DI: 880613300138BZ
Reference: CFPC-86
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Slovakia
Authorised representative: Obelis s.a.
Last updated: 01.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

EXTRAGEN ZR

IVD Class ANot specifiedOn the marketSingle use

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04562185401981
Basic UDI-DI: 456018921000200273
Reference: 0056203
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 30.06.2026 15:55

Manufacturer products Authorised representative products Authorised representative actors View details

MYCOBACTERIUM REALTIME PCR KIT

RTPCR016

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290463
Basic UDI-DI: 843604032RTPCR01601W4
Reference: RTPCR016-LP
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:33

Manufacturer products View details

Elecsys IGRA TB

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336228609
Basic UDI-DI: 761333602954BP
Reference: 09989951190
EMDN: W0105010704
EMDN description: TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)
First on market country: Germany
Authorised representative: -
Last updated: 30.06.2026 12:50

Manufacturer products View details

INNODX TB-IGRA CMIA

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

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: 06973600799831
Basic UDI-DI: 697360079019K4
Reference: KR-TB-IGRA-01050W
EMDN: W0105010704
EMDN description: TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX TB-IGRA CMIA

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

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: 06973600799824
Basic UDI-DI: 697360079019K4
Reference: KR-TB-IGRA-01020C
EMDN: W0105010704
EMDN description: TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

EasyNAT MTC Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240138
Basic UDI-DI: 697349224U2010032C000DP
Reference: U20103
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details

06970301452638

WANTAI TB-IGRA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Manufacturer SRN: CN-MF-000040626
UDI-DI: 06970301452638
Basic UDI-DI: B-06970301452638
Reference: WT-1196
EMDN: W0105010704
EMDN description: TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® MTBC OneStep Nested Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304170
Basic UDI-DI: 89080153043B268NV
Reference: 3B268
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 29.06.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

06955792731882

Mycobacterium tuberculosis (MTB) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731882
Basic UDI-DI: B-06955792731882
Reference: S3274E-48
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

06955792731875

Mycobacterium tuberculosis (MTB) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731875
Basic UDI-DI: B-06955792731875
Reference: S3274E-24
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

06955792730984

Mycobacterium Tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792730984
Basic UDI-DI: B-06955792730984
Reference: S3018E
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Mycobacterium Tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792730977
Basic UDI-DI: B-06955792730977
Reference: S3018E
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL TB-IGRA (CLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414736991
Basic UDI-DI: 695441473637JN
Reference: CLIA3147A
EMDN: W0105010704
EMDN description: TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL TB-IGRA (CLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414736557
Basic UDI-DI: 695441473637JN
Reference: CLIA3147A
EMDN: W0105010704
EMDN description: TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL TB-IGRA (CLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414736373
Basic UDI-DI: 695441473637JN
Reference: CLIA3147A
EMDN: W0105010704
EMDN description: TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL TB-IGRA (CLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414736076
Basic UDI-DI: 695441473637JN
Reference: CLIA3147A
EMDN: W0105010704
EMDN description: TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

06950917910586

Mycobacterium Tuberculosis Nucleic Acid Detection Kit (Fluorescent PCR)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Triplex International Biosciences (China) Co., LTD.
Manufacturer SRN: CN-MF-000001097
UDI-DI: 06950917910586
Basic UDI-DI: B-06950917910586
Reference: C011939
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors View details