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117 device results listed.

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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

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

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-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

D-697603130A0205EYRX57

101A0205EY，101A0205ED

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130A0205EYRX57
Basic UDI-DI: B-697603130A0205EYRX57
Reference: 101A0205EY，101A0205ED
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 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960RMTB01ZMGA

RMTB01-AHG5E, RMTB01-AHG25E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960RMTB01ZMGA
Basic UDI-DI: B-69509960RMTB01ZMGA
Reference: RMTB01-AHG5E, RMTB01-AHG25E
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 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960AMTBC01WULG

AMTBC01-AOG48E； AMTBC01-AOG96E；AMTBC01D-AOG48E； AMTBC01D-AOG96E；

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AMTBC01WULG
Basic UDI-DI: B-69509960AMTBC01WULG
Reference: AMTBC01-AOG48E； AMTBC01-AOG96E；AMTBC01D-AOG48E； AMTBC01D-AOG96E；
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 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert®

Xpert® MTB/XDR

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940007515
Basic UDI-DI: B-07332940007515
Reference: GXMTB/XDR-10
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:56

Manufacturer products View details

Xpert®

Xpert® MTB/RIF Ultra

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940002138
Basic UDI-DI: B-07332940002138
Reference: GXMTB/RIF-ULTRA-50
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

Xpert®

Xpert® MTB/RIF Ultra

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940002121
Basic UDI-DI: B-07332940002121
Reference: GXMTB/RIF-ULTRA-10
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

geneMAP

geneMAP MTB/XDR 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-TRMF000028405MTBXDRRTS7
Basic UDI-DI: B-TRMF000028405MTBXDRRTS7
Reference: MTB/XDR-RT25
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:22

Manufacturer products View details

geneMAP

geneMAP MTB Detection Kit, 100T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405MTBRT100HC
Basic UDI-DI: B-TRMF000028405MTBRT100HC
Reference: MTB-RT100
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:22

Manufacturer products View details

geneMAP

geneMAP MTB/NTM Detection Kit, 100T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405MTBNRT10LX
Basic UDI-DI: B-TRMF000028405MTBNRT10LX
Reference: MTBN-RT100
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:22

Manufacturer products View details

geneMAP

geneMAP MTB/MDR Detection Kit, 50T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405MTBMDRRTNE
Basic UDI-DI: B-TRMF000028405MTBMDRRTNE
Reference: MTB/MDR-RT50
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:22

Manufacturer products View details

D-TD-HNVC-CED-06XC

Rifampicin-resistant Mycobacterium Tuberculosis Kit (Fluorescent PCR)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Henan Vacure Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000023292
UDI-DI: D-TD-HNVC-CED-06XC
Basic UDI-DI: B-TD-HNVC-CED-06XC
Reference: /
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene MTB and NTM Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-TB02KD
Basic UDI-DI: B-TB02KD
Reference: TB02021X, TB02022X, TB02023W
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 10:55

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene Mycobacterium Tuberculosis Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-TB01KB
Basic UDI-DI: B-TB01KB
Reference: TB01021X, TB01022X, TB01023W
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 10:55

Manufacturer products Authorised representative products Authorised representative actors View details

Logix Smart MTB Test Kit

MTB-K-007

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Co-Diagnostics, Inc.
Manufacturer SRN: US-MF-000036425
UDI-DI: D-MTB-K-0074D
Basic UDI-DI: B-MTB-K-0074D
Reference: MTB-K-007
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Romania
Authorised representative: mdi Europa GmbH
Last updated: 14.07.2026 05:18

Manufacturer products Authorised representative products Authorised representative actors View details