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COVID 19 Antigen Test Kit (Colloidal Gold Method)

by Neo-nostics (Suzhou) Bioengineering Co., Ltd. China EUDAMED

Ref SVRAG89 EMDN W0105090501

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-86979834610580 Basic UDI-DIDate4 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
SVRAG89
Primary DI / UDI-DI
86979834610580
Basic UDI-DI
B-86979834610580
EMDN Code
W0105090501 Coronavirus antigen (ag) - rt & poc
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000013087
Authorised representative
OSMUNDA Medical Technology Service GmbH DE-AR-000009285

Other devices from Neo-nostics (Suzhou) Bioengineering Co., Ltd.

See all devices from Neo-nostics (Suzhou) Bioengineering Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED c896a8b6-b157-4c65-a3f1-a13b5f9fb2c5 61 fields · synced 24 Oct 2026