COVID-19&Influenza A/B&RSV&ADV Antigen combo Test

EUDAMED

Class B (EU MDR)

Ref Format (cassette): A49330;Format (pen): A49560Model Format (cassette): A4933011 A49330120 A49330140 A4933021 A49330220 A49330240 Format (pen): A4956011 A49560120 A4956021 A49560220

by Assure Tech. (Hangzhou) Co., Ltd.

Identity

Trade Name: COVID-19&Influenza A/B&RSV&ADV Antigen combo Test EUDAMED
Device Name: COVID-19&Influenza A/B&RSV&ADV Antigen combo Test EUDAMED
Model / Reference: Format (cassette): A4933011 A49330120 A49330140 A4933021 A49330220 A49330240 Format (pen): A4956011 A49560120 A4956021 A49560220 EUDAMED
Format (cassette): A49330;Format (pen): A49560 EUDAMED

Identifiers

Primary DI / UDI-DI: 06952804832223 EUDAMED
Basic UDI-DI: 69528048A49330037 EUDAMED
EMDN Code: W0105090699 OTHER MULTIPLE PATHOGENS - RT & POC EUDAMED

Classification

Device Class: Class B EUDAMED
Market of Registration: Spain EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

COVID-19&Influenza A/B&RSV&ADV Antigen combo Test by Assure Tech. (hangzhou) Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	69528048A49330037	Class B	Active

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Manufacturer

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
EUDAMED SRN: CN-MF-000002170
Authorised Representative: CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (2)

EUDAMED 5aceead9-8bd5-4f33-9f5c-ea52aa7f585e 61 fields · synced Jul 27, 2026
EUDAMED 5aceead9-8bd5-4f33-9f5c-ea52aa7f585e-1 61 fields · synced Jun 9, 2026