Skip to content

Oral Care Kit

by Sinmed Sp. z. o.o. EUDAMED

Active European Union

Ref 1035K+

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number590371932A0321003LE Basic UDI-DIDate8 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference
1035K+
Primary DI / UDI-DI
59037193139640
Basic UDI-DI
590371932A0321003LE
EMDN Code
Q019003 Dental floss and other devices for oral hygiene (for professional use)
Device Class
Class IIa
Medical Purpose
Kompleksowe rozwiązania do toalety jamy ustnej u pacjentów zaintubowanych. Prewencja VAP.

Manufacturer details

EUDAMED SRN
PL-PR-000045598

Other devices from Sinmed Sp. z. o.o.

See all devices from Sinmed Sp. z. o.o. →

Properties

Other properties (1)

  • Sterile: No