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213 device results listed.

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Xpert®

Xpert® GI Panel

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

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940009465
Basic UDI-DI: 7332940-GXGI-HG
Reference: GXGI-CE-10
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:14

Manufacturer products View details

Panther Fusion GI Bacterial Assay Controls Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045517493
Basic UDI-DI: 54200455DIAGPFGIBACUY
Reference: PRD-07116
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion GI Expanded Bacterial Assay Controls Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045517516
Basic UDI-DI: 54200455DIAGPFGIEXPBACUK
Reference: PRD-07122
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

04049095210112

RIDA®UNITY Bacterial Stool Panel

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095210112
Basic UDI-DI: 4049095UN24050000QM
Reference: UN2405
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:52

Manufacturer products View details

LiquidArray® Gastrointestinal VER 2.0

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003990
Basic UDI-DI: 40490550300001110TX
Reference: 1910680
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

LiquidArray® Gastrointestinal VER 1.0

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003846
Basic UDI-DI: 40490550300001092UN
Reference: 1896297
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

03770041419105

60407

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: ADEMTECH
Manufacturer SRN: FR-MF-000048678
UDI-DI: 03770041419105
Basic UDI-DI: 377004141960407CK
Reference: 60405
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:16

Manufacturer products View details

03770041419082

60406

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: ADEMTECH
Manufacturer SRN: FR-MF-000048678
UDI-DI: 03770041419082
Basic UDI-DI: 377004141960406CH
Reference: 60406
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:16

Manufacturer products View details

03770041419037

60405

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: ADEMTECH
Manufacturer SRN: FR-MF-000048678
UDI-DI: 03770041419037
Basic UDI-DI: 377004141960405CF
Reference: 60405
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:16

Manufacturer products View details

BIOSYNEX AMPLIQUICK Fecal Bacteriology

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

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532678607849
Basic UDI-DI: 353267F00188P98
Reference: 3150046_SEC01
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:27

Manufacturer products View details

Allplex™ GI-Bacteria(I) plus Assay

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

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101230
Basic UDI-DI: 924010GI10122BS
Reference: GI10123Z
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ GI-Bacteria(I) plus Assay

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

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101223
Basic UDI-DI: 924010GI10122BS
Reference: GI10122X
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

ChainFor™

Salmonella/Camplyobacter/Yersinia enteroclitica Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595033319
Basic UDI-DI: 868511580PCR29JJ
Reference: CFP29P50
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 30.06.2026 23:30

Manufacturer products View details

ChainFor™

Salmonella/Camplyobacter/Yersinia enteroclitica Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595031650
Basic UDI-DI: 868511580PCR29JJ
Reference: CFP29P25
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 30.06.2026 23:30

Manufacturer products View details

ChainFor™

Salmonella/Camplyobacter/Yersinia enteroclitica Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257574
Basic UDI-DI: 868511580PCR29JJ
Reference: CFP29P100
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 30.06.2026 23:29

Manufacturer products View details

06970895476126

Human Respiratory Virus Detection Kit (Fluorescent Probe-Based Real-Time PCR Assay)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895476126
Basic UDI-DI: B-06970895476126
Reference: R231T050B0C0
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 09:57

Manufacturer products Authorised representative products Authorised representative actors View details

06970895476119

Human Respiratory Virus Detection Kit (Fluorescent Probe-Based Real-Time PCR Assay)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895476119
Basic UDI-DI: B-06970895476119
Reference: R231T032B0C0
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 09:57

Manufacturer products Authorised representative products Authorised representative actors View details

06970895475785

Gastrointestional Infections Multiplex Real Time PCR Detection Kit

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895475785
Basic UDI-DI: B-06970895475785
Reference: B806T024B0C2
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Greece
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 09:56

Manufacturer products Authorised representative products Authorised representative actors View details

Enterovirus/Coxsackievirus A16/Enterovirus 71 RNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSterile

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731189
Basic UDI-DI: B-06955792731189
Reference: S3053E
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Latvia
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

Akso EV/CA16/EV71 Real-time RT-PCR Kit

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414747249
Basic UDI-DI: 695441479702KJ
Reference: RT6002
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details