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18 device results listed.

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Mycoplasma pneumoniae Antigen Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMP-502UQ
Basic UDI-DI: B-IMP-502UQ
Reference: IMP-502
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Nc036ZUEJ

Mycoplasma pneumoniae Nucleic Acid Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Nc036ZUEJ
Basic UDI-DI: B-697994388Nc036ZUEJ
Reference: Nc036
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:27

Manufacturer products Authorised representative products Authorised representative actors View details

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 pneumoniae Antigen Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMP-R502JB
Basic UDI-DI: B-IMP-R502JB
Reference: IMP-R502
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma pneumoniae Ab Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD150XD
Basic UDI-DI: B-GKPD150XD
Reference: GKPD150
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

M. pneumoniae Ag Rapid Test Cassette (Swab)

GCMP-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMP-502aHGSP
Basic UDI-DI: B-GCMP-502aHGSP
Reference: GCMP-502a
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

M. pneumoniae Ag Rapid Test Cassette (Swab)

GCMP-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMP-502a3U
Basic UDI-DI: B-GCMP-502a3U
Reference: GCMP-502a
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Mycoplasma Pneumoniae Antigen Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-1O26C5YS
Basic UDI-DI: B-1O26C5YS
Reference: 1O26C5-1-EU,1O26C5-20-EU
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 11.07.2026 14:17

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™ ADV + M. pneumoniae Combo Rapid Test Kit

VMD101

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030431
Basic UDI-DI: B-08684595030431
Reference: VMD101
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:13

Manufacturer products View details

RapidFor™ Mycoplasma pneumoniae Ag Rapid Test Kit

VMD82

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030370
Basic UDI-DI: B-08684595030370
Reference: VMD82
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:13

Manufacturer products View details

RapidFor™ Mycoplasma pneumonia (FIA)

VMPO63TD

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030035
Basic UDI-DI: B-08684595030035
Reference: VMPO63
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:12

Manufacturer products View details

06977903344613

1 test/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneSign Biotech (Xiamen)Co., Ltd.
Manufacturer SRN: CN-MF-000044463
UDI-DI: 06977903344613
Basic UDI-DI: B-06977903344613
Reference: GS110122C01
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

06977903344620

25 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneSign Biotech (Xiamen)Co., Ltd.
Manufacturer SRN: CN-MF-000044463
UDI-DI: 06977903344620
Basic UDI-DI: B-06977903344620
Reference: GS110122C25
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

DOA Rapid Urine Test Device Strip/Cassette/Panel(Colloidal Gold )

1T/box,10T/box,20T/box,25T/box,40T/box,50T/box

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698402345
Basic UDI-DI: B-06977698402345
Reference: GKPD043
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

TB IgG/lgM Rapid Test Cassette (Colloidal Gold)

1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698401416
Basic UDI-DI: B-06977698401416
Reference: GKPD031
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

M.Pneumonia Antigen Rapid Test Device

K681416D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792053182
Basic UDI-DI: B-06971792053182
Reference: K681416D
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:56

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

Mycoplasma Pneumoniae Antigen Rapid Qualitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207985
Basic UDI-DI: B-06933260207985
Reference: BT0102601
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details