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53 device results listed.

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Xpert®

Xpert® C. difficile BT

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940002299
Basic UDI-DI: B-07332940002299
Reference: GXCDIFFBT-CE-10
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

Xpert®

Xpert® C.difficile

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940000011
Basic UDI-DI: B-07332940000011
Reference: GXCDIFFICILE-CE-10
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

Clostridium botulinum Real Time PCR Kit

YJB20130NW-50T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-YJB20130NW-50TVV
Basic UDI-DI: B-YJB20130NW-50TVV
Reference: YJB20130NW-50T
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 14:02

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium botulinum Real Time PCR Kit

YJB20130NW-25T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-YJB20130NW-25TVV
Basic UDI-DI: B-YJB20130NW-25TVV
Reference: YJB20130NW-25T
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 14:02

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridioides difficile Real Time PCR Kit

IVD generalNot specifiedOn the market

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JB10130NW-50TMH
Basic UDI-DI: B-JB10130NW-50TMH
Reference: JB10130NW-50T
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:22

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridioides difficile Real Time PCR Ki

IVD generalNot specifiedOn the market

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JB10130NW-25TMH
Basic UDI-DI: B-JB10130NW-25TMH
Reference: JB10130NW-25T
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:22

Manufacturer products Authorised representative products Authorised representative actors View details

GenomEra C. difficile Assay Kit

CDX-40

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-40-02-40UPG
Basic UDI-DI: B-CDX-40-02-40UPG
Reference: CDX-40-02-40
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

GenomEra® C. difficile Assay Kit

CDX-40

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-40-02-40UC
Basic UDI-DI: B-CDX-40-02-40UC
Reference: CDX-40-02-40
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

GenomEra® C. difficile Assay Kit

CDX-40

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-40-01-40UP5
Basic UDI-DI: B-CDX-40-01-40UP5
Reference: CDX-40-01-40
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

GenomEra® C. difficile Assay Kit

CDX-40

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-40-01-40U5
Basic UDI-DI: B-CDX-40-01-40U5
Reference: CDX-40-01-40
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

GenomEra C. difficile Assay Kit

CDX-40

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-40-01-20UNT
Basic UDI-DI: B-CDX-40-01-20UNT
Reference: CDX-40-01-20
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

GenomEra® C. difficile Assay Kit

CDX-40

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-40-01-20TX
Basic UDI-DI: B-CDX-40-01-20TX
Reference: CDX-40-01-20
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

Sentosa SA C. diff PCR Test v2.0 (4x24)

300249

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953046
Basic UDI-DI: B-08885013953046
Reference: 3000249
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

LyoSens Clostridium diﬀicile toxin A/B Genotyping qPCR Kit

LYO11WS96

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548259448
Basic UDI-DI: B-08683548259448
Reference: LYO11
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:20

Manufacturer products View details

LyoSens Clostridium diﬀicile Detection qPCR Kit

LYO08

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548259417
Basic UDI-DI: B-08683548259417
Reference: LYO08
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:20

Manufacturer products View details

LyoSens Clostridium diﬀicile Detection qPCR Kit

LYO08

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548258625
Basic UDI-DI: B-08683548258625
Reference: LYO08
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:19

Manufacturer products View details

ChainFor Clostridium diﬀicile Detection qPCR Kit

CFP34

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257369
Basic UDI-DI: B-08683548257369
Reference: CFP34
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:15

Manufacturer products View details

06975447582256

12 reactions/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Igenesis(Shanghai)Co.,Ltd.
Manufacturer SRN: CN-MF-000001552
UDI-DI: 06975447582256
Basic UDI-DI: B-06975447582256
Reference: 106-0159-01
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Slovakia
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974795550474

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795550474
Basic UDI-DI: B-06974795550474
Reference: 10210110B
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:44

Manufacturer products Authorised representative products Authorised representative actors View details

06974795550467

10 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795550467
Basic UDI-DI: B-06974795550467
Reference: 10210110A
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:44

Manufacturer products Authorised representative products Authorised representative actors View details