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286 device results listed.

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06976055490063

4 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GUANGZHOU DEAOU GENE TECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000033028
UDI-DI: 06976055490063
Basic UDI-DI: B-06976055490063
Reference: NA
EMDN: W0105010803
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

VIUICK

Diagnostic Kit for Mycoplasma Pneumoniae DNA (Real-Time PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Viuick Biotechnology Co.,LTD.
Manufacturer SRN: CN-MF-000017369
UDI-DI: 06975400320093
Basic UDI-DI: B-06975400320093
Reference: 48 Tests/Kit
EMDN: W0105010899
EMDN description: MYCOPLASMA / UREAPLASMA REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:30

Manufacturer products Authorised representative products Authorised representative actors View details

06975132463013

Mycoplasma pneumoniae IgM /Chlamydia pneumoniae IgM Antibody Test Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000004533
UDI-DI: 06975132463013
Basic UDI-DI: B-06975132463013
Reference: IMC-402G-20
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

06975102280190

GENEYE® Mycoplasma Pneumoniae Assay

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Suzhou GenDx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018830
UDI-DI: 06975102280190
Basic UDI-DI: B-06975102280190
Reference: RP003
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 21:56

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma hominis Real-time PCR Kit

ITSZ094001

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nexlab Co., Ltd.
Manufacturer SRN: CN-MF-000047094
UDI-DI: 06974912093754
Basic UDI-DI: B-06974912093754
Reference: ITSZ094001
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 21:02

Manufacturer products Authorised representative products Authorised representative actors View details

Ureaplasma urealyticum Real-time PCR Kit

ITSZ092001

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nexlab Co., Ltd.
Manufacturer SRN: CN-MF-000047094
UDI-DI: 06974912093747
Basic UDI-DI: B-06974912093747
Reference: ITSZ092001
EMDN: W010501080303
EMDN description: UREAPLASMA DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 21:02

Manufacturer products Authorised representative products Authorised representative actors View details

06974858560341

Mycoplasma Pneumoniae (MP) Nucleic Acid Detection Kit (Fluorescence PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Suzhou TianLong Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001080
UDI-DI: 06974858560341
Basic UDI-DI: B-06974858560341
Reference: P181H
EMDN: W0105010803
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:58

Manufacturer products Authorised representative products Authorised representative actors View details

06974858560112

Mycoplasma Pneumoniae (MP) Nucleic Acid Detection Kit (Fluorescence PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Suzhou TianLong Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001080
UDI-DI: 06974858560112
Basic UDI-DI: B-06974858560112
Reference: P109H
EMDN: W0105010803
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:58

Manufacturer products Authorised representative products Authorised representative actors View details

06974858560068

Ureaplasma Urealyticum (UU) Nucleic Acid Detection Kit (Fluorescence PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Suzhou TianLong Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001080
UDI-DI: 06974858560068
Basic UDI-DI: B-06974858560068
Reference: P178H
EMDN: W0105010803
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

06974858560051

Ureaplasma Urealyticum (UU) Nucleic Acid Detection Kit (Fluorescence PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Suzhou TianLong Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001080
UDI-DI: 06974858560051
Basic UDI-DI: B-06974858560051
Reference: P105H
EMDN: W0105010803
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma pneumoniae IgG Antibody Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620537
Basic UDI-DI: B-06974854620537
Reference: P2200625
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma pneumoniae IgM Antibody Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620513
Basic UDI-DI: B-06974854620513
Reference: P2200525
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FlashDetect™ LyocartE NG&UU Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767392026
Basic UDI-DI: B-06974767392026
Reference: 6018011902-CE
EMDN: W0105010803
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:42

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FlashDetect™ LyocartE MG&TV&MH Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767392002
Basic UDI-DI: B-06974767392002
Reference: 6018012502-CE
EMDN: W0105010803
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:42

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FlashDetect™ LyocartE NG&UU Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767391555
Basic UDI-DI: B-06974767391555
Reference: 6018011905-CE
EMDN: W0105010803
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:41

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FlashDetect™ LyocartE MG&TV&MH Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767391517
Basic UDI-DI: B-06974767391517
Reference: 6018012505-CE
EMDN: W0105010803
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:41

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma Pneumonia IgM Rapid Test Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303056
Basic UDI-DI: B-06974566303056
Reference: LMP0120
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Denmark
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma cultivation/Identiﬁcation/ Enumeration/ Susceptibility Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566302189
Basic UDI-DI: B-06974566302189
Reference: LMP0120
EMDN: W0105010899
EMDN description: MYCOPLASMA / UREAPLASMA REAGENTS - OTHER
First on market country: Denmark
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

06974323012986

PCR-based Ureaplasma Urealyticum Test Kit (Fluorometric PCR)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012986
Basic UDI-DI: B-06974323012986
Reference: ID024
EMDN: W010501080303
EMDN description: UREAPLASMA DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:52

Manufacturer products Authorised representative products Authorised representative actors View details

06974323012979

PCR-based Ureaplasma Urealyticum Test Kit (Fluorometric PCR)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012979
Basic UDI-DI: B-06974323012979
Reference: ID024
EMDN: W010501080303
EMDN description: UREAPLASMA DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:52

Manufacturer products Authorised representative products Authorised representative actors View details