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165 device results listed.

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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

06974323011286

Real-time PCR Diagnostic Kit for Rapid Detection of Clostridium difficile

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323011286
Basic UDI-DI: B-06974323011286
Reference: A2340
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

06974323011279

Real-time PCR Diagnostic Kit for Rapid Detection of Clostridium difficile

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323011279
Basic UDI-DI: B-06974323011279
Reference: A2340
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium difficile Antigen Rapid Tes

Clostridium difficile Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238911121
Basic UDI-DI: B-06974238911121
Reference: HCDI058G
EMDN: W0105011801
EMDN description: C.DIFFICILE GDH DETECTION
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium dificile GDH, Toxin A and Toxin B Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910711
Basic UDI-DI: B-06974238910711
Reference: HCDT067G
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium Difficile Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042225215
Basic UDI-DI: B-06971042225215
Reference: DD-0166-02
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

PreventID® C. diff Combo Tox A + B

IVD generalIVDDOn the marketKitReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598013469
Basic UDI-DI: B-04050598013469
Reference: KSTICDT625GP
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:50

Manufacturer products View details

PreventID® C. diff Combo Tox A + B

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598013452
Basic UDI-DI: B-04050598013452
Reference: KSTICDT625G10
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:50

Manufacturer products View details

MutaPLEX C. difficile, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598009448
Basic UDI-DI: B-04050598009448
Reference: KG194396
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:48

Manufacturer products View details

STANDARD™ M10 C. difficile BT

M10-CBT-01

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111723117
Basic UDI-DI: 88001117IPBA01MA05WV
Reference: 11CDC20A
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

CLOSTRIDIUM DIFFICILE GDH Ag VIRCLIA® MONOTEST

VCM108

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

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290678
Basic UDI-DI: 843661029VCM10801M3
Reference: VCM108
EMDN: W0105011801
EMDN description: C.DIFFICILE GDH DETECTION
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:58

Manufacturer products View details

CLOSTRIDIUM DIFFICILE TOXINS REAL TIME PCR KIT

RTPCR020

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290173
Basic UDI-DI: 843661029RTPCR020017V
Reference: RTPCR020-LP
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:57

Manufacturer products View details

CerTest CLIA Clostridium difficile Toxin A/B Ag

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440259039
Basic UDI-DI: 84354402CLIGASTROB_CDXYC
Reference: CL-CDX001
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:04

Manufacturer products View details

CHORUS CLIA CLOSTRIDIUM DIFFICILE A/B TOXINS

CCAB-C

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891322779
Basic UDI-DI: 803389132CCAB-C0099
Reference: 82308
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:15

Manufacturer products View details

CHORUS CLIA CLOSTRIDIUM DIFFICILE GDH

CCGDH-C

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891322748
Basic UDI-DI: 803389132CCGDH-C00QA
Reference: 82306
EMDN: W0105011801
EMDN description: C.DIFFICILE GDH DETECTION
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:15

Manufacturer products View details

Nucleic Acid Detection Kit for Clostridium Difficile toxin A/B gene (Fluorescence PCR)

HWTS-EV032A

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366198
Basic UDI-DI: 697484936HWTS-EV032AYS
Reference: HWTS-EV032A
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

04049095140327

RIDA®QUICK Clostridium difficile GDH

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095140327
Basic UDI-DI: 4049095N070300000VP
Reference: NP0704
EMDN: W0105011801
EMDN description: C.DIFFICILE GDH DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:50

Manufacturer products View details

04049095140242

RIDA®QUICK Clostridium difficile Toxin A/B

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095140242
Basic UDI-DI: 4049095N080300000WA
Reference: N0803
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:50

Manufacturer products View details

04049095030116

RIDASCREEN® Clostridium difficile GDH

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095030116
Basic UDI-DI: 4049095C070100000JW
Reference: C0701
EMDN: W0105011801
EMDN description: C.DIFFICILE GDH DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:50

Manufacturer products View details

04049095030017

RIDASCREEN® Clostridium difficile Toxin A/B

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095030017
Basic UDI-DI: 4049095C080100000KH
Reference: C0801
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:49

Manufacturer products View details