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131 device results listed.

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U-Card™ 200

VRE Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850209
Basic UDI-DI: B-06933289850209
Reference: WR47P0006
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

VRE Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850193
Basic UDI-DI: B-06933289850193
Reference: WR47P0005
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

VRE Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850186
Basic UDI-DI: B-06933289850186
Reference: WR47P0004
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

VIASURE

VIASURE Mycoplasma genitalium with Macrolide Resistance Assay for BD MAX™ System (2x12 tubes, 24 test)

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440258704
Basic UDI-DI: 84354402MDXRESISTC_BMGMHP
Reference: 444224
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 06.08.2026 23:01

Manufacturer products View details

D0020-Ureaplasma urealyticum-Positive PCR-Control

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430973
Basic UDI-DI: B-04262420430973
Reference: D0020
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:45

Manufacturer products View details

PerioPOC Pro

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GENSPEED Biotech
Manufacturer SRN: AT-MF-000013008
UDI-DI: 09120131770052
Basic UDI-DI: B-09120131770052
Reference: PPTK002
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 16:50

Manufacturer products View details

06955792735460

Vibrio Parahaemolyticus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735460
Basic UDI-DI: B-06955792735460
Reference: S3208E-48
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:09

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735453

Vibrio Parahaemolyticus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735453
Basic UDI-DI: B-06955792735453
Reference: S3208E-24
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:09

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735385

Bacterial Vaginosis Pathogen Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735385
Basic UDI-DI: B-06955792735385
Reference: S3266E-48
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:09

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735378

Bacterial Vaginosis Pathogen Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735378
Basic UDI-DI: B-06955792735378
Reference: S3266E-24
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:09

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735248

12 Human Gut Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735248
Basic UDI-DI: B-06955792735248
Reference: S3243E-48
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:08

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735231

12 Human Gut Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735231
Basic UDI-DI: B-06955792735231
Reference: S3243E-24
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:08

Manufacturer products Authorised representative products Authorised representative actors View details

06955792734470

Vibrio Vulnificus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792734470
Basic UDI-DI: B-06955792734470
Reference: S3249E-48
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:05

Manufacturer products Authorised representative products Authorised representative actors View details

06955792734463

Vibrio Vulnificus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792734463
Basic UDI-DI: B-06955792734463
Reference: S3249E-24
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:05

Manufacturer products Authorised representative products Authorised representative actors View details

06955792734371

Shigella/Salmonella/Escherichia coli O157 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792734371
Basic UDI-DI: B-06955792734371
Reference: S3229E-48
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:05

Manufacturer products Authorised representative products Authorised representative actors View details

06955792734364

Shigella/Salmonella/Escherichia coli O157 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792734364
Basic UDI-DI: B-06955792734364
Reference: S3229E-24
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:05

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium Perfringens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792734227
Basic UDI-DI: B-06955792734227
Reference: S3248E-48
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:04

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium Perfringens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792734210
Basic UDI-DI: B-06955792734210
Reference: S3248E-24
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:04

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732490

Bacillus anthracis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732490
Basic UDI-DI: B-06955792732490
Reference: S3299E-48
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
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

06955792732483

Bacillus anthracis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732483
Basic UDI-DI: B-06955792732483
Reference: S3299E-24
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
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