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ILabU zestaw do samodzielnego pobierania próbki: ślina

by IlabU Sp. z o.o.

Ref ILS004

Active European Union

CE MDR

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/MDR Number59079905794saliva29 Basic UDI-DI 05907990579408UDI-DIDate20 Jan 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Model / Reference
ILS004
Primary DI / UDI-DI
05907990579408
Basic UDI-DI
59079905794saliva29
EMDN Code
W05019002 Saliva collection devices
Device Class
Class I
Medical Purpose
Zestaw jest przeznaczony do samodzielnego pobrania śliny w warunkach domowych, a następnie przesłania próbki do laboratorium w celu dalszej analizy.

Manufacturer details

EUDAMED SRN
PL-PR-000047472

Other devices from IlabU Sp. z o.o.

Properties

Other properties (1)

  • Sterile: No