SARS-CoV-2 & Flu & RSV Antigen Combo Rapid Test

EUDAMED

Class IVD General (EU MDR)

Ref P211144Ref P211147

by Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.

Identity

Trade Name: SARS-CoV-2 & Flu & RSV Antigen Combo Rapid Test EUDAMED
Device Name: SARS-CoV-2 & Flu & RSV Antigen Combo Rapid Test EUDAMED
Model / Reference: P211144 EUDAMED
P211147 EUDAMED

Identifiers

Primary DI / UDI-DI: 16972698601368 EUDAMED
16972698604284 EUDAMED
Basic UDI-DI: B-16972698601368 EUDAMED
B-16972698604284 EUDAMED
EMDN Code: W0105070599 MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER EUDAMED
W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

EUDAMEDEUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

SARS-CoV-2 & Flu & RSV Antigen Combo Rapid Test by Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

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-16972698601368	Class IVD General	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
EUDAMED SRN: CN-MF-000013495
Authorised Representative: CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (2)

EUDAMED eb28f63c-650c-4ab5-89e9-a969af438e13 61 fields · synced Oct 6, 2026
EUDAMED 199dec75-486a-4572-83d0-02b6d7e79baa 61 fields · synced May 18, 2026