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129 device results listed.

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RapidFor™

VMD96

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548254993
Basic UDI-DI: 868354825VMD96TD4G
Reference: VMD96TD
EMDN: W0105011803
EMDN description: C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 01:22

Manufacturer products View details

01220000260061

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260061
Basic UDI-DI: 122000026NATCSOKN
Reference: NATCSO-6MC-IVD
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 22.09.2026 00:11

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™

VMD88

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548254191
Basic UDI-DI: 868354825VMD88TD4K
Reference: VMD88TD
EMDN: W0105011801
EMDN description: C.DIFFICILE GDH DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 23:28

Manufacturer products View details

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

04049095210068

RIDA®UNITY C. difficile

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095210068
Basic UDI-DI: 4049095UN08350000SS
Reference: UN0835
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 22:21

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

Clostridium difficile GDH Rapid Test Cassette (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277511247
Basic UDI-DI: B-06970277511247
Reference: ICDG-602
EMDN: W0105011801
EMDN description: C.DIFFICILE GDH DETECTION
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium difficile DNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732612
Basic UDI-DI: B-06955792732612
Reference: S3096E
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

DyonCDA

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: DYONMED SA
Manufacturer SRN: GR-MF-000033588
UDI-DI: 05200251200036
Basic UDI-DI: B-05200251200036
Reference: DNCT105
EMDN: W0105011801
EMDN description: C.DIFFICILE GDH DETECTION
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:47

Manufacturer products View details

Clostridium difficile GDH+Toxin A+Toxin B Combo, Rapid Test Cassette (Feces), positive controls included Test rapid determinare Clostridium difficile GDH+Toxina A+Toxina B, caseta COMBO (materii fecale) cu controale pozitive swab incluse

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use

Manufacturer: VitroBioChem SRL
Manufacturer SRN: RO-MF-000010877
UDI-DI: 05944759080126
Basic UDI-DI: 5944759080VTCDABGDH25B6X8
Reference: VT-CDABGDH-25
EMDN: W0105011803
EMDN description: C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:25

Manufacturer products View details

VIDAS® C. difficile GDH

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026334819
Basic UDI-DI: 357302BUDI000588UB
Reference: 30125
EMDN: W0105011801
EMDN description: C.DIFFICILE GDH DETECTION
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

Manufacturer products 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 GDH

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147176792
Basic UDI-DI: B-86060147176792
Reference: N1802V24CDGDH
EMDN: W0105011801
EMDN description: C.DIFFICILE GDH 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