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Influenza A/B&ADV Antigen combo Test

EUDAMED

Class B (EU MDR)

Ref Format (cassette): A4D330;Format (pen): A4D360Model Format (cassette): A4D33011 A4D330120 A4D330140 A4D33021 A4D330220 A4D330240 Format (pen): A4D36011 A4D360120 A4D36021 A4D360220

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

Identity

Trade Name
Influenza A/B&ADV Antigen combo Test EUDAMED
Device Name
Influenza A/B&ADV Antigen combo Test EUDAMED
Model / Reference
Format (cassette): A4D33011 A4D330120 A4D330140 A4D33021 A4D330220 A4D330240 Format (pen): A4D36011 A4D360120 A4D36021 A4D360220 EUDAMED
Format (cassette): A4D330;Format (pen): A4D360 EUDAMED

Identifiers

Primary DI / UDI-DI
06952804832407 EUDAMED
Basic UDI-DI
69528048A4D33006M 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

Influenza A/B&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

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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 1afcba1b-4899-4710-9bcd-e861e04da984 61 fields · synced Jul 9, 2026
  • EUDAMED 1afcba1b-4899-4710-9bcd-e861e04da984-1 61 fields · synced Jun 10, 2026
  • EUDAMED 1afcba1b-4899-4710-9bcd-e861e04da984-2 61 fields · synced Jun 10, 2026