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TULA® Kit

by CeramOptec GmbH EUDAMED

Active European Union

Ref 503100415

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number404905962NL Basic UDI-DIDate2 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
TULA® Kit
Model / Reference
503100415
Primary DI / UDI-DI
04049059519428
Basic UDI-DI
404905962NL
EMDN Code
Z12011085 Laser surgery instruments - consumables
Device Class
Class IIa
Medical Purpose
This procedure Pack is intended to be used in the outpatient transurethral laser ablation (TULA) for urothelial tumors using the 980 nm and / or 1470 nm diode laser. Bladder tumor must be non-muscle invasive and graded G1/2 pTa TCC recurrences.

Manufacturer details

EUDAMED SRN
DE-PR-000052739

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Properties

Other properties (1)

  • Sterile: No