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138 device results listed.

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06955792734739

Candida Albicans, Cryptococcus Neoformans and Pneumocystis Jiroveci 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: 06955792734739
Basic UDI-DI: B-06955792734739
Reference: S3142E-24
EMDN: W0105070202
EMDN description: BLOOD STREAM INFECTION/SEPSIS (BACTERIA & FUNGI) - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

06955792734722

Candida Albicans, Acinetobacter Baumannii and Pneumocystis Jiroveci 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: 06955792734722
Basic UDI-DI: B-06955792734722
Reference: S3141E-48
EMDN: W0105070202
EMDN description: BLOOD STREAM INFECTION/SEPSIS (BACTERIA & FUNGI) - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

06955792734715

Candida Albicans, Acinetobacter Baumannii and Pneumocystis Jiroveci 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: 06955792734715
Basic UDI-DI: B-06955792734715
Reference: S3141E-24
EMDN: W0105070202
EMDN description: BLOOD STREAM INFECTION/SEPSIS (BACTERIA & FUNGI) - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732391

Acinetobacter baumannii and Canidia albican 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: 06955792732391
Basic UDI-DI: B-06955792732391
Reference: S3100E
EMDN: W0105070202
EMDN description: BLOOD STREAM INFECTION/SEPSIS (BACTERIA & FUNGI) - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details

Acinetobacter baumannii and Canidia albican Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732384
Basic UDI-DI: B-06955792732384
Reference: S3100E
EMDN: W0105070202
EMDN description: BLOOD STREAM INFECTION/SEPSIS (BACTERIA & FUNGI) - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details

06930317891258

20 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317891258
Basic UDI-DI: B-06930317891258
Reference: DNK-2508-1
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.08.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

BioFire® Blood Culture Identification 2 (BCID2) Panel

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020338
Basic UDI-DI: 357302BUDI000001SC
Reference: RFIT-ASY-0147
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 29.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Nc010ZABW

Shigella/Entamoeba histolytica Nucleic Acid Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Nc010ZABW
Basic UDI-DI: B-697994388Nc010ZABW
Reference: Nc010
EMDN: W0105070201
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:26

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Fa010W45T

Shigella/Entamoeba histolytica Nucleic Acid Detection Kit (Fluorescence)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Fa010W45T
Basic UDI-DI: B-697994388Fa010W45T
Reference: Fa010
EMDN: W0105070201
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:19

Manufacturer products Authorised representative products Authorised representative actors View details

Sepsis-Q Real Time PCR Kit

G2M804026,G2M804026R

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M804026FE
Basic UDI-DI: B-G2M804026FE
Reference: G2M804026,G2M804026
EMDN: W0105070202
EMDN description: BLOOD STREAM INFECTION/SEPSIS (BACTERIA & FUNGI) - MULTIPLEX NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

Neisseria Gonorrhoeae Antigen Rapid Test Kit(Colloidal gold method)