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iLESSYS® Biportal Sterilization Tray IUT532475-1

by Joimax, Inc. EUDAMEDGUDID

Active European Union

Ref IUT532475-1

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42503371CONTHJ Basic UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250337120728 UDI-DIDate29 Sep 2023ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
iLESSYS® Biportal Sterilization Tray
Generic Name
Instrument tray, reusable
Device Name
CESSYS® Dorsal Access Tray
Model / Ref / Catalog
IUT532475-1
Primary DI / UDI-DI
04250337120728
Basic UDI-DI
42503371CONTHJ
FDA Product Code
FSM
EMDN Code
S010401 Trays, baskets, tubs for sterilisation and their components
GMDN Term
Instrument tray, reusable
Device Class
Class I
Regulation Number
878.4800
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Instrument tray, reusable

Other devices from Joimax, Inc.

See all devices from Joimax, Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No