COVID-19/Influenza A+B/RSV/Adenovirus/MP Antigen Combo Rapid Test

EUDAMED

Class IVD General (EU MDR)

Ref RV-G65a

by Hangzhou Aichek Medical Technology Co., Ltd.

Identity

Trade Name: COVID-19/Influenza A+B/RSV/Adenovirus/MP Antigen Combo Rapid Test EUDAMED
Device Name: COVID-19/Influenza A+B/RSV/Adenovirus/MP Antigen Combo Rapid Test EUDAMED
Model / Reference: RV-G65a EUDAMED

Identifiers

Primary DI / UDI-DI: D-RV-G65a28 EUDAMED
Basic UDI-DI: B-RV-G65a28 EUDAMED
EMDN Code: W0105090699 OTHER MULTIPLE PATHOGENS - RT & POC 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

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

COVID-19/Influenza A+B/RSV/Adenovirus/MP Antigen Combo Rapid Test by Hangzhou Aichek Medical Technology 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-RV-G65a28	Class IVD General	Active

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

Manufacturer

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
EUDAMED SRN: CN-MF-000028093
Authorised Representative: Medunion S.L. ES-AR-000019366

Sources (1)

EUDAMED 06dad15d-0ad5-4363-9277-2a98b960e85d 61 fields · synced Oct 6, 2026