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

EUDAMED

Class B (EU MDR)

Ref A4D730Model Format (cassette): A4D73011 A4D730120 A4D730140 A4D73021 A4D730220 A4D730240Ref CFRAH1NST-5Model CassetteRef CFRAH1NST-10

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

Identity

Trade Name
COVID-19&Influenza A/B&RSV&ADV&MP&HMPV Antigen combo Test EUDAMED
COVID-19 & Influenza A+B & RSV & ADV & HMPV Antigen Combo Test Kit (LFA) EUDAMED
Device Name
COVID-19&Influenza A/B&RSV&ADV&MP&HMPV Antigen combo Test EUDAMED
COVID-19 & Influenza A+B & RSV & ADV & HMPV Antigen Combo Test Kit (LFA) EUDAMED
Model / Reference
Format (cassette): A4D73011 A4D730120 A4D730140 A4D73021 A4D730220 A4D730240 EUDAMED
A4D730 EUDAMED
Cassette EUDAMED
CFRAH1NST-5 EUDAMED
CFRAH1NST-10 EUDAMED

Identifiers

Primary DI / UDI-DI
06952804833022 EUDAMED
06952062712381 EUDAMED
06952062712398 EUDAMED
Basic UDI-DI
69528048A4D73007H EUDAMED
69520627J161LM EUDAMED
Unit of Use DI
06952062713456 EUDAMED
EMDN Code
W0105090699 OTHER MULTIPLE PATHOGENS - RT & POC EUDAMED
W0105070399 MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER EUDAMED

Classification

Device Class
Class B EUDAMED
Class C EUDAMED
Market of Registration
Spain EUDAMED
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMEDEUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMEDEUDAMED

Self Testing

No

EUDAMEDEUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMEDEUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

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

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 0beaad04-295f-49fe-8731-16475e6f1c95 61 fields · synced Oct 6, 2026
  • EUDAMED 29b88654-1604-4891-8e5e-be8ad093ad71 61 fields · synced Jun 20, 2026
  • EUDAMED ae295f23-98a3-40c0-99f4-5a6803e19e0f 61 fields · synced Jul 28, 2026