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18 device results listed.

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AMPLIRUN® MYCOPLASMA GENITALIUM DNA CONTROL

MBC085

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040322338
Basic UDI-DI: 843604032MBC085013Q
Reference: MBC085
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

AMPLIRUN® MYCOPLASMA HOMINIS DNA CONTROL

MBC084

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040322321
Basic UDI-DI: 843604032MBC084013K
Reference: MBC084
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

AMPLIRUN® MYCOPLASMA PNEUMONIAE DNA CONTROL

MBC035

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040321850
Basic UDI-DI: 843604032MBC035012M
Reference: MBC035
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:47

Manufacturer products 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

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

RevoDx Mycoplasma pneumoniae qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212632
Basic UDI-DI: B-08684387212632
Reference: IP202328-100
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:54

Manufacturer products View details

RevoDx Mycoplasma pneumoniae qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212625
Basic UDI-DI: B-08684387212625
Reference: IP202328-25
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:54

Manufacturer products View details

LyoSens Mycoplasma pneumoniae qPCR Kit

LYO34WS96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548259240
Basic UDI-DI: B-08683548259240
Reference: LYO34
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:20

Manufacturer products View details

TaqPath™ Menu | GeneProof™ Mycoplasma pneumoniae PCR Kit

GeneProof Mycoplasma pneumoniae PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696304089
Basic UDI-DI: B-08595696304089
Reference: A58210
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:59

Manufacturer products View details

GeneProof Mycoplasma pneumoniae PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161952176
Basic UDI-DI: B-08594161952176
Reference: MP/ISEX/100
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:48

Manufacturer products View details

GeneProof Mycoplasma pneumoniae PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161952152
Basic UDI-DI: B-08594161952152
Reference: MP/ISEX/025
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:48

Manufacturer products 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

06974323010883

Real-time PCR Detection Kit for Mycoplasma Pneumoniae

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323010883
Basic UDI-DI: B-06974323010883
Reference: ID041
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

06974323010876

Real-time PCR Detection Kit for Mycoplasma Pneumoniae

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323010876
Basic UDI-DI: B-06974323010876
Reference: ID041
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

Mycoplasma Pneumoniae Nucleic Acid Detection Kit (Fluorescent PCR)

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

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227870
Basic UDI-DI: 697384322BSJ09JS
Reference: BSJ09M1
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma Pneumoniae Nucleic Acid Detection Kit (Fluorescent PCR)

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

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227887
Basic UDI-DI: 697384322BSJ09JS
Reference: BSJ09S1
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details