YJSeq 300 Dx Sequencing Kit

by Shanghai YJMED BioTechnology Co., Ltd. China EUDAMED

Ref FCP 300cyclesModel 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Withdrawn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 300cycles

Primary DI / UDI-DI: 06977334213120
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

Other devices from Shanghai YJMED BioTechnology Co., Ltd.

YJSeq 300 Dx Sequencing System

Class A
Solid Tumor Multi-gene Combined Detection Kit ( Reversible Terminator Sequencing)

IVD General
Solid Tumor Multi-gene Combined Detection Kit (Reversible Terminator Sequencing)

IVD General
YJSeq 300 Dx Sequencing Kit

Class A
YJSeq 300 Dx Sequencing Kit

Class A
YJSeq 300 Dx Sequencing Kit

Class A

See all devices from Shanghai YJMED BioTechnology Co., Ltd. →

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 b2fb875c-e49d-4af9-bebc-94705a6ea7b3 61 fields · synced 24 Oct 2026