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41 device results listed.

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RapidFor™

VMD89

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548254214
Basic UDI-DI: 868354825VMD89TD4Q
Reference: VMD89TD
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 23:28

Manufacturer products View details

U-CardDx™ 200

C.difficile Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289853927
Basic UDI-DI: B-06933289853927
Reference: WR89P0003
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDx™ 200

C.difficile Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289853910
Basic UDI-DI: B-06933289853910
Reference: WR89P0002
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDx™ 200

C.difficile Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289853903
Basic UDI-DI: B-06933289853903
Reference: WR89P0001
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

VIDAS® C. difficile Toxin A & B

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064204
Basic UDI-DI: 357302BUDI000587U9
Reference: 30118
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:47

Manufacturer products View details

Clostridium difficile Toxin A+B

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147176860
Basic UDI-DI: B-86060147176860
Reference: N1803V24CDTAB
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 30.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium difficile Toxin A+B

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313276530
Basic UDI-DI: B-86060313276530
Reference: C1803V24CDT
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 30.07.2026 02:29

Manufacturer products Authorised representative products Authorised representative actors View details

Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

HWTS-EV032A

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849369762
Basic UDI-DI: 697484936HWTS-EV032AYS
Reference: W0105011802
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: 23.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849369779
Basic UDI-DI: 697484936HWTS-EV032AYS
Reference: HWTS-EVO32HL
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 23.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849369786
Basic UDI-DI: 697484936HWTS-EV032AYS
Reference: HWTS-EVO32HO
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 23.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

04099466104038

Serazym® Clostridium difficile Toxin A+B

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466104038
Basic UDI-DI: B-04099466104038
Reference: E-040
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details

Clostridium difficile Toxin A&B Rapid Test Casette (Feces)

GCCD(Toxin A/B)-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCD(ToxinAB)-602aZC
Basic UDI-DI: B-GCCD(ToxinAB)-602aZC
Reference: GCCD(Toxin A/B)-602a
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

mariPOC® Clostridium difficile Toxin A/B test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-2R04ES
Basic UDI-DI: B-2R04ES
Reference: 2R04
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 16:58

Manufacturer products View details

RevoDx Clostridium difficile qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387211895
Basic UDI-DI: B-08684387211895
Reference: IP202409-500
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 01:51

Manufacturer products View details

RevoDx Clostridium difficile qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387211888
Basic UDI-DI: B-08684387211888
Reference: IP202409-100
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 01:51

Manufacturer products View details

RevoDx Clostridium difficile qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387211871
Basic UDI-DI: B-08684387211871
Reference: IP202409-50
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 01:51

Manufacturer products View details

LyoSens Clostridium difficile toxins A+B Detection qPCR Kit

LYO23

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548258779
Basic UDI-DI: B-08683548258779
Reference: LYO23
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:19

Manufacturer products View details

LyoSens Clostridium diﬀicile toxin B Detection qPCR Kit

LYO10

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548258649
Basic UDI-DI: B-08683548258649
Reference: LYO10
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:19

Manufacturer products View details

LyoSens Clostridium diﬀicile toxin A Detection qPCR Kit

LYO09

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548258632
Basic UDI-DI: B-08683548258632
Reference: LYO09
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:19

Manufacturer products View details

ChainFor Clostridium diﬀicile Binary Toxin A/B Detection qPCR Kit

CFP37

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257390
Basic UDI-DI: B-08683548257390
Reference: CFP37
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:15

Manufacturer products View details