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52 device results listed.

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Accu-Tell® Clostridium difficile GDH Cassette (Feces)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581432122
Basic UDI-DI: B-06970581432122
Reference: ABT-IDT-B315
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:48

Manufacturer products Authorised representative products Authorised representative actors View details

C. difficile GDH FIA

GDH-F23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804803827
Basic UDI-DI: B-06952804803827
Reference: GDH-F23F3
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:25

Manufacturer products Authorised representative products Authorised representative actors View details

C. difficile Toxin A/B+GDH Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339209351
Basic UDI-DI: B-06937339209351
Reference: VITG-637
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

C. difficile Toxin A/B Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339207531
Basic UDI-DI: B-06937339207531
Reference: VICT-627
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

05902643958371

IVD Class BNot specifiedOn the marketSingle use

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958371
Basic UDI-DI: 59026439BRT320JA
Reference: 1-321-K020
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 21.06.2026 17:11

Manufacturer products View details

04049095140648

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095140648
Basic UDI-DI: 4049095N082300000XC
Reference: NP0824
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 22:40

Manufacturer products View details

SIMPLE GDH / STICK GDH

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577004082
Basic UDI-DI: 84295779045XX
Reference: 9.045.020.15.000
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

SIMPLE GDH / STICK GDH

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577004891
Basic UDI-DI: 84295779045XX
Reference: 9.045.020.71.000
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

SIMPLE GDH / STICK GDH

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577007816
Basic UDI-DI: 84295779045XX
Reference: 9.045.020.16.000
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

Simple GDH-Toxins

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577007878
Basic UDI-DI: 84295779065Y5
Reference: 9.065.020.15.000
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

Simple GDH-Toxins

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577007885
Basic UDI-DI: 84295779065Y5
Reference: 9.065.020.16.000
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

Simple GDH-Toxins

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577007892
Basic UDI-DI: 84295779065Y5
Reference: 9.065.020.71.000
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details