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277 device results listed.

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06928103000519

20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103000519
Basic UDI-DI: B-06928103000519
Reference: DA0051
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

06928103000502

20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103000502
Basic UDI-DI: B-06928103000502
Reference: DA0050
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Biocard Mycoplasma pneumoniae IgM

3-035-000

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingSingle useSterile

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06416842035010
Basic UDI-DI: B-06416842035010
Reference: 3-035-000
EMDN: W0105010702
EMDN description: MYCOBACTERIAL ANTIBODY ASSAYS
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:47

Manufacturer products View details

05061059980380

ZENA MAX Mycobacterium Tuberculosis Real Time PCR Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Advanced Molecular Diagnostics Ltd
Manufacturer SRN: UK-MF-000043044
UDI-DI: 05061059980380
Basic UDI-DI: B-05061059980380
Reference: KD145983-100
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 02.08.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

04562185395303

TRCReady MTB

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04562185395303
Basic UDI-DI: B-04562185395303
Reference: 0056101
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:50

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: 08436040329436
Basic UDI-DI: 843604032RTPCR01601W4
Reference: RTPCR016-LPD
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:49

Manufacturer products View details

06955792743700

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

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743700
Basic UDI-DI: 69557927S3354E000001TQ
Reference: S3354E-48
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

T-SPOT.TB

TB.300

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Oxford Immunotec Ltd
Manufacturer SRN: GB-MF-000004429
UDI-DI: 05051716000018
Basic UDI-DI: 5051716TBRB
Reference: TB.300
EMDN: W0105010704
EMDN description: TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)
First on market country: Belgium
Safety summary (SSCP/SSP): TD-TB-01 SSP-01 · Rev. R1
Authorised representative: Wallac Oy
Last updated: 31.07.2026 08:06

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

PATHFAST TB LAM Ag

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

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301162
Basic UDI-DI: 4987595PF1231KXJ
Reference: 30116
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: PHC Europe B.V.
Last updated: 31.07.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

Loopamp™ MTBC Detection Kit

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: EIKEN CHEMICAL CO., LTD.
Manufacturer SRN: JP-MF-000018097
UDI-DI: 04033145191377
Basic UDI-DI: 4987026TD-LFTBZE
Reference: 972000
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Human Gesellschaft für Biochemica und Diagnostica mbH
Last updated: 31.07.2026 07:30

Manufacturer products Authorised representative products Authorised representative actors View details

VIDAS® TB-IGRA

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026608576
Basic UDI-DI: 357302BUDI000853U7
Reference: 423111
EMDN: W0105010704
EMDN description: TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:58

Manufacturer products View details

LIAISON® QuantiFERON®-TB Gold Plus II

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

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771104388
Basic UDI-DI: 80567713110903Y
Reference: 311090
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:40

Manufacturer products View details

LIAISON® QuantiFERON®-TB Gold Plus II

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

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771104395
Basic UDI-DI: 80567713110954A
Reference: 311095
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:40

Manufacturer products View details

LIAISON® QuantiFERON®-TB Gold Plus

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

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771104180
Basic UDI-DI: 80567713110503L
Reference: 311050
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

Manufacturer products View details

LIAISON® QuantiFERON®-TB Gold Plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771103282
Basic UDI-DI: B-08056771103282
Reference: 311010
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

Manufacturer products View details

MTB-NTM Multiplex Real-Time PCR Kit

G2M707421

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M707421FY
Basic UDI-DI: B-G2M707421FY
Reference: G2M707421,G2M707421R
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 17.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Nc046228Y

Non-tuberculous Mycobacterium Nucleic Acid Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Nc046228Y
Basic UDI-DI: B-697994388Nc046228Y
Reference: Nc046
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Fa046WR98

Non-tuberculous Mycobacterium Nucleic Acid Detection Kit (Fluorescence)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Fa046WR98
Basic UDI-DI: B-697994388Fa046WR98
Reference: Fa046
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-697603130CMTBRIF01A4ULZ

CMTBRIF01A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130CMTBRIF01A4ULZ
Basic UDI-DI: B-697603130CMTBRIF01A4ULZ
Reference: CMTBRIF01A-AHG4E
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-697603130CMTB01AHG46

CMTB01A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130CMTB01AHG46
Basic UDI-DI: B-697603130CMTB01AHG46
Reference: CMTB01A-AHG4E
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details