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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

22.09.2026 11:56

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89 device results listed.

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Mycoplasma Pneumoniae Rapid Antigen Test (Colloidal Gold Method)

IVD generalIVDDNo longer on the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732018
Basic UDI-DI: B-06955792732018
Reference: S3346E-1
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 22.09.2026 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma Pneumoniae Rapid Antigen Test (Colloidal Gold Method)

IVD generalIVDDNo longer on the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732025
Basic UDI-DI: B-06955792732025
Reference: S3346E-25
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 22.09.2026 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma Pneumoniae Rapid Antigen Test (Colloidal Gold Method)

IVD generalIVDDNo longer on the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732032
Basic UDI-DI: B-06955792732032
Reference: S3346E-50
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 22.09.2026 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

(MP) Mycoplasma Pneumoniae Test

Strip & Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140297
Basic UDI-DI: B-06958982140297
Reference: AH61-20
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Italy
Authorised representative: Sungo Cert GmbH
Last updated: 05.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma pneumonia IgM (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289859363
Basic UDI-DI: B-06933289859363
Reference: WA56P0008
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma pneumonia IgM (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289859356
Basic UDI-DI: B-06933289859356
Reference: WA56P0007
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma pneumonia IgM (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289859349
Basic UDI-DI: B-06933289859349
Reference: WA56P0006
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma pneumonia IgM (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289859332
Basic UDI-DI: B-06933289859332
Reference: WA56P0005
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma Pneumoniae IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289859325
Basic UDI-DI: B-06933289859325
Reference: WA55P0004
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma Pneumoniae IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289859318
Basic UDI-DI: B-06933289859318
Reference: WA55P0003
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma Pneumoniae IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289859301
Basic UDI-DI: B-06933289859301
Reference: WA55P0002
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma Pneumoniae IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289859295
Basic UDI-DI: B-06933289859295
Reference: WA55P0001
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

MYCOPLASMA PNEUMONIAE ELISA IgG/IgM

G/M1015

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320358
Basic UDI-DI: B-08436040320358
Reference: G/M1015
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

Manufacturer products View details

MYCOPLASMA PNEUMONIAE ELISA IgG

G1002

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320341
Basic UDI-DI: B-08436040320341
Reference: G1002
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

Manufacturer products View details

MYCOPLASMA PNEUMONIAE ELISA IgM

M1002

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320334
Basic UDI-DI: B-08436040320334
Reference: M1002
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

Manufacturer products View details

200 tests

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802667
Basic UDI-DI: B-06930317802667
Reference: DNK-1901-46
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:39

Manufacturer products Authorised representative products Authorised representative actors View details

100 tests

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802650
Basic UDI-DI: B-06930317802650
Reference: DNK-1901-46
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:38

Manufacturer products Authorised representative products Authorised representative actors View details

200 tests

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802643
Basic UDI-DI: B-06930317802643
Reference: DNK-1901-45
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:38

Manufacturer products Authorised representative products Authorised representative actors View details

100 tests

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802636
Basic UDI-DI: B-06930317802636
Reference: DNK-1901-45
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:38

Manufacturer products Authorised representative products Authorised representative actors View details

MYCOPLASMA PNEUMONIAE VIRCLIA® IgM MONOTEST

VCM064

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

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040326145
Basic UDI-DI: 843604032VCM06401D3
Reference: VCM064
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details