Skip to content

SARS-CoV-2/Influenza A+B/RSV/Adenovirus/ M.pneumoniae Antigen Combo Rapid Test

by Hangzhou Alltest Biotech.Co., Ltd.

Ref IRT-555, VISIRAM-767Model VISIRAM

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-06936983134903 Basic UDI-DI Date21 Dec 2023RegisteredStatusActive

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  • Withdrawn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

Trade Name
SARS-CoV-2/Influenza A+B/RSV/Adenovirus/ M.pneumoniae Antigen Combo Rapid Test
SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Ag
Device Name
SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Ag Combo Rapid Test
Model / Reference
IRT-555, VISIRAM, VISIRAM-767
Primary DI / UDI-DI
06936983134903, 06937339210296
Basic UDI-DI
B-06936983134903, B-06937339210296
EMDN Code
W0105070599, W0105099099
Device Class
Class IVD General
EU market of registration
Netherlands
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000010710
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Hangzhou Alltest Biotech.Co., Ltd.

See all devices from Hangzhou Alltest Biotech.Co., Ltd. →

Properties

  • Animal Tissues YesEUDAMEDNoEUDAMED
  • Reagent
  • Professional Testing

Other properties (7)

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