Influenza A&B Rapid Test Kit

by Jiangsu Bioperfectus Technologies Co., Ltd. EUDAMED

Active European Union

Ref SC10101W-25T

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-SC10101W-25TUG Basic UDI-DI	Date14 Aug 2023Registered	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Withdrawn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: SC10101W-25T

Primary DI / UDI-DI: D-SC10101W-25TUG
Basic UDI-DI: B-SC10101W-25TUG
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-000014691
Authorised representative: MedNet EC-REP GmbH DE-AR-000000002

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Properties

Animal Tissues
Microbial Substances
Reagent
Near-Patient Testing
Professional Testing

Other properties (5)

Sterile: No
Human Tissues: No
Self Testing: No
Companion Diagnostics: No
Surgical Instrument: No