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286 device results listed.

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Allplex™ MG & MoxiR Assay

Allplex™ MG & MoxiR Assay

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102343
Basic UDI-DI: 924010SD10234GH
Reference: SD10234X
EMDN: W0105010899
EMDN description: MYCOPLASMA / UREAPLASMA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ MG & MoxiR Assay

Allplex™ MG & MoxiR Assay

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102336
Basic UDI-DI: 924010SD10234GH
Reference: SD10233Y
EMDN: W0105010899
EMDN description: MYCOPLASMA / UREAPLASMA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ MG & MoxiR Assay

Allplex™ MG & MoxiR Assay

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102329
Basic UDI-DI: 924010SD10234GH
Reference: SD10232Z
EMDN: W0105010899
EMDN description: MYCOPLASMA / UREAPLASMA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ MG & AziR Assay

Allplex™ MG & AziR Assay

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101704
Basic UDI-DI: 924010SD10170GG
Reference: SD10170X
EMDN: W0105010899
EMDN description: MYCOPLASMA / UREAPLASMA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ MG & AziR Assay

Allplex™ MG & AziR Assay

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101698
Basic UDI-DI: 924010SD10170GG
Reference: SD10169Y
EMDN: W0105010899
EMDN description: MYCOPLASMA / UREAPLASMA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

GeneProof Mycoplasma genitalium/hominis PCR Kit

GeneProof Mycoplasma genitalium/hominis PCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696300326
Basic UDI-DI: 859569630010Q4
Reference: MGH/GP/100
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:58

Manufacturer products View details

GeneProof Mycoplasma genitalium/hominis PCR Kit

GeneProof Mycoplasma genitalium/hominis PCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696300319
Basic UDI-DI: 859569630010Q4
Reference: MGH/GP/025
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:58

Manufacturer products View details

CHORUS MYCOPLASMA PNEUMONIAE IgA

CHORUSMYA

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891327552
Basic UDI-DI: 803389132CHORUSMYA00B6
Reference: 81033
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:43

Manufacturer products View details

CHORUS MYCOPLASMA PNEUMONIAE IgM

CHORUSMYM

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891322267
Basic UDI-DI: 803389132CHORUSMYM00D2
Reference: 81035
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:43

Manufacturer products View details

CHORUS MYCOPLASMA PNEUMONIAE IgG

CHORUSMYG

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891322250
Basic UDI-DI: 803389132CHORUSMYG00C4
Reference: 81034
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:43

Manufacturer products View details

EasyNAT UU Assay

EasyNAT UU Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240213
Basic UDI-DI: 697349224U2030032C000F5
Reference: U20303
EMDN: W0105010803
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details

EasyNAT MP Assay

EasyNAT MP Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240169
Basic UDI-DI: 697349224U2020012C000DL
Reference: U20201
EMDN: W0105010803
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details

EasyNAT MG Assay

EasyNAT MG Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240145
Basic UDI-DI: 697349224U2030022C000EQ
Reference: U20302
EMDN: W0105010803
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Mycoplasma genitalium Assay

-

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509153
Basic UDI-DI: 54200455DIAGAPTMGENY9
Reference: PRD-03374
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma Pneumoniae 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: 06955792731011
Basic UDI-DI: B-06955792731011
Reference: S3016E
EMDN: W0105010803
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma Pneumoniae DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Mycoplasma Pneumoniae DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731004
Basic UDI-DI: B-06955792731004
Reference: S3016E
EMDN: W0105010803
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma pneumoniae Antigen Rapid Test

MP-S23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827120
Basic UDI-DI: B-06952804827120
Reference: MP-S23
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

IM4410040 IM4411040 IM4414040 IM4415040

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617416784
Basic UDI-DI: 69506174IM441040D7
Reference: IM4410040
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
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

IM4410040 IM4411040 IM4414040 IM4415040

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617416760
Basic UDI-DI: 69506174IM441040D7
Reference: IM4411040
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
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

IM4410040 IM4411040 IM4414040 IM4415040

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617416524
Basic UDI-DI: 69506174IM441040D7
Reference: IM4415040
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
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