Influenza A/B Antigen Rapid Test（Swab）

by Safecare Biotech (Hangzhou) Co., Ltd. EUDAMED

Active European Union

Ref FLU-6022

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-697424646FLU001KJZP Basic UDI-DI	Date21 May 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference: FLU-6022

Primary DI / UDI-DI: D-697424646FLU001KJZP
Basic UDI-DI: B-697424646FLU001KJZP
EMDN Code: W0105099004 Influenza a and /or b - rt & poc

Device Class: Class IVD General
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000019109
Authorised representative: Wellkang Ltd XI-AR-000001836

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Properties

Animal Tissues
Reagent
Professional Testing

Other properties (7)

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