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AccuSaliva Viral Collection Kit

by Accugene, Inc.

Ref ACN M61.02Model ACN M11.01

Active European Union

CE IVDR

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/IVDR Number88000542SACVZ Basic UDI-DI 08800054200348UDI-DIDate2 Oct 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
AccuSaliva Collection Kit
Model / Reference
ACN M11.01, ACN M61.02
Primary DI / UDI-DI
08800054200348
Basic UDI-DI
88000542SACVZ
EMDN Code
W0104010204 Sample transport for na testing
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000058798
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Accugene, Inc.

See all devices from Accugene, Inc. →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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