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106 device results listed.

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Mycoplasma Pneumoniae Nucleic Acid Detection Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807172091Q3
Basic UDI-DI: B-000012807172091Q3
Reference: HWTS-RT024
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus MG

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000016
Basic UDI-DI: 9352224020001W6
Reference: 20001L-01
EMDN: W010501080304
EMDN description: MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 04.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma Pneumoniae Nucleic Acid Detection Kit (Fluorescent PCR)

BSJ09S1, BSJ09M1, BSJ09L1

IVD Class BIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227801
Basic UDI-DI: 697384322BSJ09JS
Reference: BSJ09L1
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Greece
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:02

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: 15420045509146
Basic UDI-DI: 54200455DIAGAPTMGENY9
Reference: PRD-03374
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

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

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

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

06955792731011

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)

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

ResistancePlus MG(550)

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000023
Basic UDI-DI: 9352224020001W6
Reference: 2000201
EMDN: W010501080304
EMDN description: MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.06.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus MG Positive Control

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000047
Basic UDI-DI: 9352224020001W6
Reference: 95001
EMDN: W010501080304
EMDN description: MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.06.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus MG(675)

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000191
Basic UDI-DI: 9352224020001W6
Reference: 2000301
EMDN: W010501080304
EMDN description: MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.06.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus MG

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000207
Basic UDI-DI: 9352224020001W6
Reference: 2000125
EMDN: W010501080304
EMDN description: MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.06.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus MG(550)

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000214
Basic UDI-DI: 9352224020001W6
Reference: 2000225
EMDN: W010501080304
EMDN description: MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.06.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus MG(675)

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000221
Basic UDI-DI: 9352224020001W6
Reference: 2000325
EMDN: W010501080304
EMDN description: MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.06.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus MG FleXible

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000382
Basic UDI-DI: 9352224020001W6
Reference: S2A-2000410
EMDN: W010501080304
EMDN description: MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.06.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus MG S2A Positive Control

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000399
Basic UDI-DI: 9352224020001W6
Reference: S2A-95004
EMDN: W010501080304
EMDN description: MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.06.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details