Influenza A&B Rapid Test Kit

EUDAMED

Class IVD General (EU MDR)

Ref SC10101W-50T

by Jiangsu Bioperfectus Technologies Co., Ltd.

Identity

Trade Name: Influenza A&B Rapid Test Kit EUDAMED
Device Name: Influenza A&B Rapid Test Kit EUDAMED
Model / Reference: SC10101W-50T EUDAMED

Identifiers

Primary DI / UDI-DI: D-SC10101W-50TUG EUDAMED
Basic UDI-DI: B-SC10101W-50TUG EUDAMED
EMDN Code: W0105099004 INFLUENZA A AND /OR B - RT & POC EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Influenza A&B Rapid Test Kit by Jiangsu Bioperfectus Technologies Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-SC10101W-50TUG	Class IVD General	Active

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Manufacturer

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
EUDAMED SRN: CN-MF-000014691
Authorised Representative: MedNet EC-REP GmbH DE-AR-000000002

Sources (1)

EUDAMED 568b757e-1adb-4b09-9cf8-98d1e2b4559f 61 fields · synced Jun 20, 2026