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01.08.2026 13:11

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220 device results listed.

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D-697994388Fa036WN8R

Mycoplasma pneumoniae 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-697994388Fa036WN8R
Basic UDI-DI: B-697994388Fa036WN8R
Reference: Fa036
EMDN: W0105010899
EMDN description: MYCOPLASMA / UREAPLASMA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-697603130101A0207EGRVH

101A0207EY,101A0207ED

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130101A0207EGRVH
Basic UDI-DI: B-697603130101A0207EGRVH
Reference: 101A0207EY,101A0207ED
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma Antigen Rapid Test

Mycoplasma Antigen Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840313390
Basic UDI-DI: B-69743840313390
Reference: 3022202
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma IgM Rapid Test

Mycoplasma IgM Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840312546
Basic UDI-DI: B-69743840312546
Reference: 3022201
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960AMP01RKTR

AMP01-AOG48E; AMP01-AOG96E; AMP01D-AOG48E; AMP01D-AOG96E

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AMP01RKTR
Basic UDI-DI: B-69509960AMP01RKTR
Reference: AMP01-AOG48E; AMP01-AOG96E; AMP01D-AOG48E; AMP01D-AOG96E
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma pneumoniae IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE587910O
Basic UDI-DI: B-+ENTIRE587910O
Reference: RE58791
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

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Mycoplasma pneumoniae IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE587810N
Basic UDI-DI: B-+ENTIRE587810N
Reference: RE58781
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

Mycoplasma pneumoniae IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE587710M
Basic UDI-DI: B-+ENTIRE587710M
Reference: RE58771
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

+ENTIMYCM0350DS06

NovaLisa® Mycoplasma pneumoniae IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIMYCM0350DS06
Basic UDI-DI: B-+ENTIMYCM0350DS06
Reference: MYCM0350DS
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

Manufacturer products View details

+ENTIMYCM035008

NovaLisa® Mycoplasma pneumoniae IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIMYCM035008
Basic UDI-DI: B-+ENTIMYCM035008
Reference: MYCM0350
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

Manufacturer products View details

+ENTIMYCG0350DS00

NovaLisa® Mycoplasma pneumoniae IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIMYCG0350DS00
Basic UDI-DI: B-+ENTIMYCG0350DS00
Reference: MYCG0350DS
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details

+ENTIMYCG035002

NovaLisa® Mycoplasma pneumoniae IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIMYCG035002
Basic UDI-DI: B-+ENTIMYCG035002
Reference: MYCG0350
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details

+ENTIMYCA0350DS0.

NovaLisa® Mycoplasma pneumoniae IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIMYCA0350DS0.
Basic UDI-DI: B-+ENTIMYCA0350DS0.
Reference: MYCA0350DS
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details

geneMAP STI Panel 3 Assay, 50T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405STI3RT50JS
Basic UDI-DI: B-TRMF000028405STI3RT50JS
Reference: STI3-RT50
EMDN: W0105010803
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:23

Manufacturer products View details

geneMAP STI Panel 2 Assay, 50T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405STI2RT50JF
Basic UDI-DI: B-TRMF000028405STI2RT50JF
Reference: STI2-RT50
EMDN: W0105010803
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:23

Manufacturer products View details

geneMAP STI Panel 1 Assay, 50T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405STI1RT50J4
Basic UDI-DI: B-TRMF000028405STI1RT50J4
Reference: STI1-RT50
EMDN: W0105010803
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:23

Manufacturer products View details

Cowingene Mycoplasma Genitalium and Mycoplasma Hominis Detection Kit

Cowingene Mycoplasma Genitalium and Mycoplasma Hominis Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-ST12N3
Basic UDI-DI: B-ST12N3
Reference: ST12021X, ST12022X, ST12023W
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

MYCOKIT SERO

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Eurobio Scientific
Manufacturer SRN: FR-MF-000011745
UDI-DI: D-PL10011MM
Basic UDI-DI: B-PL10011MM
Reference: PL10011
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: France
Authorised representative: -
Last updated: 14.07.2026 09:45

Manufacturer products View details

Mycoplasma IgM Rapid Test

Mycoplasma IgM Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: D-MycoplasmaIgMLE
Basic UDI-DI: B-MycoplasmaIgMLE
Reference: Cassette
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 14.07.2026 05:19

Manufacturer products Authorised representative products Authorised representative actors View details

MYCO WELL D-ONE LIQUI SCREEN

MS01349

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-MS01349PZ
Basic UDI-DI: B-MS01349PZ
Reference: MS01349
EMDN: W0105010899
EMDN description: MYCOPLASMA / UREAPLASMA REAGENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 05:13

Manufacturer products View details