Skip to content

DNA Collection Kit (Circle Premium; Circle Vital; Circle Health; Circle Family Plan)

by Prenetics Limited

Ref DN-0101

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number489715326DN-01017P Basic UDI-DI 48971532600184UDI-DIDate11 Aug 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  • Withdrawn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

Model / Reference
DN-0101
Primary DI / UDI-DI
48971532600184
Basic UDI-DI
489715326DN-01017P
Direct Marketing DI
48971532600184
EMDN Code
W05019099 Samples collection devices - other
Models / Variants
Device Class
Class A
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
HK-MF-000050661
Authorised representative
Obelis s.a. BE-AR-000000106

Properties

  • Self Testing

Other properties (10)

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