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COVID-19&Influenza A/B Antigen combo Test

EUDAMED

Class B (EU MDR)

Ref Format (cassette): A494301;Format (pen): A47660Model Format (cassette): A4943011 A49430120 A49430140 A4943021 A49430220 A49430240 Format (pen): A4766011 A47660120 A4766021 A47660220

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

Identity

Trade Name
COVID-19&Influenza A/B Antigen combo Test EUDAMED
Device Name
COVID-19&Influenza A/B Antigen combo Test EUDAMED
Model / Reference
Format (cassette): A4943011 A49430120 A49430140 A4943021 A49430220 A49430240 Format (pen): A4766011 A47660120 A4766021 A47660220 EUDAMED
Format (cassette): A494301;Format (pen): A47660 EUDAMED

Identifiers

Primary DI / UDI-DI
06952804832094 EUDAMED
Basic UDI-DI
69528048A4943003E EUDAMED
EMDN Code
W0105090699 OTHER MULTIPLE PATHOGENS - RT & POC EUDAMED

Classification

Device Class
Class B EUDAMED
Market of Registration
Spain EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

COVID-19&Influenza A/B 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

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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 24e30039-36b4-4b4c-b8f4-d161ae685037 61 fields · synced Jun 18, 2026
  • EUDAMED 24e30039-36b4-4b4c-b8f4-d161ae685037-1 61 fields · synced Jun 10, 2026