C-reactive protein (hsCRP + routine CRP) test kit (fluorescence immunochromatography)

by Sanqi Biomedical(Shandong)Co., Ltd. EUDAMED

Active European Union

Ref 5298Model 3Q-FA1000

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number697447273025MP Basic UDI-DI	Date7 Jun 2023Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference: 3Q-FA1000, 5298

Primary DI / UDI-DI: 06974472730250, 06974472730267
Basic UDI-DI: 697447273025MP, 697447273026MR
EMDN Code: W0102160601 C-reactive protein - rt & poc

Device Class: Class A
Market of Registration: France

Manufacturer details

EUDAMED SRN: CN-MF-000030641
Authorised representative: Lotus NL B.V. NL-AR-000000121

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Properties

Sterile YesEUDAMEDNoEUDAMED
Reagent
Professional Testing
Companion Diagnostics

Other properties (7)

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