Novel Coronavirus Antigen Test Kit(Latex beads)

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

Active European Union

Ref 5480Model 3Q-FA1000

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number697447273036MU 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Withdrawn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, 5480

Primary DI / UDI-DI: 06974472730366
Basic UDI-DI: 697447273036MU
EMDN Code: W0103030501 Other antigen typing reagents

Device Class: Class A
Market of Registration: Germany

Manufacturer details

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

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Properties

Show properties

Reagent
Professional Testing
Companion Diagnostics

Other properties (8)

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