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139 device results listed.

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06974737220847

AmpSure® Chlamydia Trachomatis (CT) RNA Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai Rendu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000018869
UDI-DI: 06974737220847
Basic UDI-DI: 697473722CTRT2R6
Reference: CTRT2-100CE
EMDN: W0105010117
EMDN description: CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS
First on market country: Greece
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

06970895476072

Mycoplasma pneumoniae and Macrolides-resistant strain nucleic acid test kit

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895476072
Basic UDI-DI: B-06970895476072
Reference: R061T016B0C1
EMDN: W0105010118
EMDN description: CHLAMYDIA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Greece
Authorised representative: SUNGO Europe B.V.
Last updated: 30.06.2026 09:56

Manufacturer products Authorised representative products Authorised representative actors View details

06970895475594

Mycoplasma Pneumoniae and Macrolides-Resistant Strain Nucleic Acid Test Kit

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895475594
Basic UDI-DI: B-06970895475594
Reference: R061T050B0C1
EMDN: W0105010118
EMDN description: CHLAMYDIA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Greece
Authorised representative: SUNGO Europe B.V.
Last updated: 30.06.2026 09:55

Manufacturer products Authorised representative products Authorised representative actors View details

06970895475570

Mycoplasma Pneumoniae and Macrolides-Resistant Strain Nucleic Acid Test Kit

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895475570
Basic UDI-DI: B-06970895475570
Reference: R061T016B0C1
EMDN: W0105010118
EMDN description: CHLAMYDIA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Greece
Authorised representative: SUNGO Europe B.V.
Last updated: 30.06.2026 09:55

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Chlamydia trachomatis Assay

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045505414
Basic UDI-DI: 54200455DIAGAPTCTRA
Reference: 302925
EMDN: W0105010117
EMDN description: CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Chlamydia Trachomatis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD Annex II List BIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792730755
Basic UDI-DI: B-06955792730755
Reference: S3001E
EMDN: W0105010117
EMDN description: CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

06950617418283

EIM4410016 EIM4411016 EIM4414016 EIM4415016

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617418283
Basic UDI-DI: 69506174IM441016DA
Reference: EIM4415016
EMDN: W0105010116
EMDN description: CHLAMYDIA PNEUMONIAE ANTIBODY IGM
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details

06950617418276

EIM4410016 EIM4411016 EIM4414016 EIM4415016

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617418276
Basic UDI-DI: 69506174IM441016DA
Reference: EIM4414016
EMDN: W0105010116
EMDN description: CHLAMYDIA PNEUMONIAE ANTIBODY IGM
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details

06950617418269

EIM4410016 EIM4411016 EIM4414016 EIM4415016

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617418269
Basic UDI-DI: 69506174IM441016DA
Reference: EIM4411016
EMDN: W0105010116
EMDN description: CHLAMYDIA PNEUMONIAE ANTIBODY IGM
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details

06950617418252

EIM4410016 EIM4411016 EIM4414016 EIM4415016

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617418252
Basic UDI-DI: 69506174IM441016DA
Reference: EIM4410016
EMDN: W0105010116
EMDN description: CHLAMYDIA PNEUMONIAE ANTIBODY IGM
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details

06950617418214

EIM4410015 EIM4411015 EIM4414015 EIM4415015

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617418214
Basic UDI-DI: 69506174IM441015D8
Reference: EIM4415015
EMDN: W0105010115
EMDN description: CHLAMYDIA PNEUMONAIE ANTIBODY IGG
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details

06950617418207

EIM4410015 EIM4411015 EIM4414015 EIM4415015

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617418207
Basic UDI-DI: 69506174IM441015D8
Reference: EIM4414015
EMDN: W0105010115
EMDN description: CHLAMYDIA PNEUMONAIE ANTIBODY IGG
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details

06950617416388

EIM4410015 EIM4411015 EIM4414015 EIM4415015

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617416388
Basic UDI-DI: 69506174IM441015D8
Reference: EIM4411015
EMDN: W0105010115
EMDN description: CHLAMYDIA PNEUMONAIE ANTIBODY IGG
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:45

Manufacturer products Authorised representative products Authorised representative actors View details

06950617409755

EIM4410015 EIM4411015 EIM4414015 EIM4415015

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617409755
Basic UDI-DI: 69506174IM441015D8
Reference: EIM4410015
EMDN: W0105010115
EMDN description: CHLAMYDIA PNEUMONAIE ANTIBODY IGG
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:45

Manufacturer products Authorised representative products Authorised representative actors View details

Chlamydia trachomatis IgA EIA