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Irrigation Needle

by TiaDent Inc EUDAMED

Active European Union

Ref TIN.27.25.2HModel TiaEndo Irrigation Needles: TIN.27.25.2H, TIN.30.25.2HTiaEndo Irrigation Needles Elite: TINE.27.25.2H, TINE.30.25.2H, TINE.27.25.1H, TINE.30.25.1H, TIN.27.25.1H, TIN.30.25.1H

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081019026TINBW Basic UDI-DIDate4 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Irrigation Needle
Model / Reference
TiaEndo Irrigation Needles: TIN.27.25.2H, TIN.30.25.2HTiaEndo Irrigation Needles Elite: TINE.27.25.2H, TINE.30.25.2H, TINE.27.25.1H, TINE.30.25.1H, TIN.27.25.1H, TIN.30.25.1H, TIN.27.25.2H
Primary DI / UDI-DI
00810190260234
Basic UDI-DI
081019026TINBW
EMDN Code
A010602 Dental irrigation needles
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000049704
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from TiaDent Inc

See all devices from TiaDent Inc →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No