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Respiratory Multiple Rapid Test (Flu A/Flu B/COVID-19/RSV/Adeno)

by Diasia Biomedical Technology Co., Ltd.

Ref R411321, R411323, R411322Model 25 Tests/kit, 100 Tests/kit, 50 Tests/Kit

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06973316743111 Basic UDI-DI Date17 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Respiratory Multiple Rapid Test (Flu A/Flu B/COVID-19/RSV/Adeno)
Model / Reference
25 Tests/kit, R411321, 100 Tests/kit, R411323, 50 Tests/Kit, R411322
Primary DI / UDI-DI
06973316743111, 06973316743135, 06973316743128
Basic UDI-DI
B-06973316743111, B-06973316743135, B-06973316743128
EMDN Code
W0105090699 Other multiple pathogens - rt & poc
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000010281
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Diasia Biomedical Technology Co., Ltd.

See all devices from Diasia Biomedical Technology Co., Ltd. →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No