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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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06955792743700

Mycobacterium tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743700
Basic UDI-DI: 69557927S3354E000001TQ
Reference: S3354E-48
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743557

Monkeypox virus Nucleic Acid Diagnostic Kit (LAMP)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743557
Basic UDI-DI: B-06955792743557
Reference: S3361E-48
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: OSEN GmbH
Last updated: 28.06.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743540

Monkeypox virus Nucleic Acid Diagnostic Kit (LAMP)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743540
Basic UDI-DI: B-06955792743540
Reference: S3361E-24
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: OSEN GmbH
Last updated: 28.06.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743533

15 High-risk Human Papillomavirus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743533
Basic UDI-DI: B-06955792743533
Reference: S3359E-12
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: France
Authorised representative: OSEN GmbH
Last updated: 28.06.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743526

15 High-risk Human Papillomavirus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743526
Basic UDI-DI: B-06955792743526
Reference: S3359E-48
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: France
Authorised representative: OSEN GmbH
Last updated: 28.06.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743519

Monkeypox Virus (MPV) Rapid Antibody Test Kit (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743519
Basic UDI-DI: B-06955792743519
Reference: S3358E-50
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: France
Authorised representative: OSEN GmbH
Last updated: 28.06.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743502

Monkeypox Virus (MPV) Rapid Antibody Test Kit (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743502
Basic UDI-DI: B-06955792743502
Reference: S3358E-25
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: France
Authorised representative: OSEN GmbH
Last updated: 28.06.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743496

Monkeypox Virus (MPV) Rapid Antibody Test Kit (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743496
Basic UDI-DI: B-06955792743496
Reference: S3358E-5
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: France
Authorised representative: OSEN GmbH
Last updated: 28.06.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743489

Monkeypox Virus (MPV) Rapid Antibody Test Kit (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743489
Basic UDI-DI: B-06955792743489
Reference: S3358E-1
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: France
Authorised representative: OSEN GmbH
Last updated: 28.06.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743472

Monkeypox Virus (MPV) Rapid Antigen Test Kit (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743472
Basic UDI-DI: B-06955792743472
Reference: S3356E-50
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: France
Authorised representative: OSEN GmbH
Last updated: 28.06.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus (MPV) Rapid Antigen Test Kit (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743458
Basic UDI-DI: B-06955792743458
Reference: S3356E-5
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: France
Authorised representative: OSEN GmbH
Last updated: 28.06.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743441

Monkeypox Virus (MPV) Rapid Antigen Test Kit (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743441
Basic UDI-DI: B-06955792743441
Reference: S3356E-1
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: France
Authorised representative: OSEN GmbH
Last updated: 28.06.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743434

Human ALDH2 Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743434
Basic UDI-DI: B-06955792743434
Reference: S3351E-24-P
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743427

Respiratory Syncytial Virus Rapid Antigen Test (Colloidal Gold Method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743427
Basic UDI-DI: B-06955792743427
Reference: S3347E-50
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743410

Respiratory Syncytial Virus Rapid Antigen Test (Colloidal Gold Method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743410
Basic UDI-DI: B-06955792743410
Reference: S3347E-25
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743403

Respiratory Syncytial Virus Rapid Antigen Test (Colloidal Gold Method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743403
Basic UDI-DI: B-06955792743403
Reference: S3347E-1
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743397

SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743397
Basic UDI-DI: B-06955792743397
Reference: S3344E-15
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743380

SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743380
Basic UDI-DI: B-06955792743380
Reference: S3344E-1
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743373

SARS-CoV-2 Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743373
Basic UDI-DI: B-06955792743373
Reference: S3343E-15
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743366

SARS-CoV-2 Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743366
Basic UDI-DI: B-06955792743366
Reference: S3343E-1
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details