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COVID-19& Influenza A/B& RSV Antigen Combo Test

EUDAMED

Class B (EU MDR)

Ref Format (cassette): A49810;Format (pen): A47760Model Format (cassette): A4981011 A49810120 A49810140 A4981021 A49810220 A49810240 Format (pen): A4776011 A47760120 A4776021 A47760220

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

Identity

Trade Name
COVID-19& Influenza A/B& RSV Antigen Combo Test EUDAMED
Device Name
COVID-19& Influenza A/B& RSV Antigen Combo Test EUDAMED
Model / Reference
Format (cassette): A4981011 A49810120 A49810140 A4981021 A49810220 A49810240 Format (pen): A4776011 A47760120 A4776021 A47760220 EUDAMED
Format (cassette): A49810;Format (pen): A47760 EUDAMED

Identifiers

Primary DI / UDI-DI
06952804832124 EUDAMED
Basic UDI-DI
69528048A4981003Y 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& RSV 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 (3)

  • EUDAMED af0cd25c-0b26-4532-838d-4474fae8f243 61 fields · synced Jun 17, 2026
  • EUDAMED af0cd25c-0b26-4532-838d-4474fae8f243-1 61 fields · synced Jun 9, 2026
  • EUDAMED af0cd25c-0b26-4532-838d-4474fae8f243-2 61 fields · synced Jun 9, 2026