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Medotex SARS-CoV-2 Antigen Rapid Test

by Medotex Biotech (HangZhou) Co., Ltd. EUDAMED

Active European Union

Ref 40 Tests

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06979890910017 Basic UDI-DIDate29 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
SARS-CoV-2 Antigen Rapid Test
Model / Reference
40 Tests
Primary DI / UDI-DI
06979890910017
Basic UDI-DI
B-06979890910017
EMDN Code
W0105090501 Coronavirus antigen (ag) - rt & poc
Device Class
Class IVD General
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000051631
Authorised representative
HUMISS TRADING S. L. ES-AR-000040177

Other devices from Medotex Biotech (HangZhou) Co., Ltd.

See all devices from Medotex Biotech (HangZhou) 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