YJSeq 300 Dx Sequencing Kit

by Shanghai YJMED BioTechnology Co., Ltd. China EUDAMED

Ref FCP-D SE075-DModel YJSeq 300 Dx Kit EMDN W02050185

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number697733421RB01KG Basic UDI-DI	Date10 Jun 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference: YJSeq 300 Dx Kit, FCP-D SE075-D

Primary DI / UDI-DI: 06977334213106
Basic UDI-DI: 697733421RB01KG
EMDN Code: W02050185 Nucleic acid testing instruments except micro-arrays - consumables

Device Class: Class A
Market of Registration: Spain

Manufacturer details

EUDAMED SRN: CN-MF-000055692
Authorised representative: Medunion S.L. ES-AR-000019366

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Properties & raw data

Show properties, registry sources and raw records

Reagent
Professional Testing

Other properties (9)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No
New Device: No

Sources (1)

EUDAMED 00ba0f6b-fa68-479b-b395-0a4d3427fbcc 61 fields · synced 24 Oct 2026