Public EUDAMED Search

EUDAMED Device Search

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

Last updated

20.09.2026 13:24

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Active filter:Manufacturer SRN:CN-MF-000018830

4 device results listed.

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GCP-30/GE4/GD-220

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Suzhou GenDx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018830
UDI-DI: 06975102280169
Basic UDI-DI: 697510228GD0017D
Reference: GCP-30
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 02:45

Manufacturer products Authorised representative products Authorised representative actors View details

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

GENEYE® Respiratory Syncytial Virus（RSV）ERA Assay

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Suzhou GenDx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018830
UDI-DI: 06975102280183
Basic UDI-DI: B-06975102280183
Reference: RP002
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - 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

GENEYE® Influenza Virus （FluA/B）ERA Assay

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Suzhou GenDx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018830
UDI-DI: 06975102280176
Basic UDI-DI: B-06975102280176
Reference: RP001
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - 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