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SARS-CoV-2+FluA+B+RSV+Adeno Combo Test Kit(Colloidal Gold)

by Hunan Runmei Gene Technology Co., Ltd.

Ref COV-01-AG

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-06979845480015 Basic UDI-DI 06979845480015UDI-DIDate6 Feb 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  • Withdrawn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

Model / Reference
COV-01-AG
Primary DI / UDI-DI
06979845480015
Basic UDI-DI
B-06979845480015
EMDN Code
Q01020203 Occlusal waxes
Device Class
Class IVD General
EU market of registration
Cyprus

Manufacturer details

EUDAMED SRN
CN-MF-000017635
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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