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iLESSYS® TNC5828AL

by Joimax, Inc.

Part of a family of 59 devices: see the family page

Ref TNC5828AL

iLESSYS® TNC5828AL is a device classified as Class I in the EU and Class II in the US made by Joimax, Inc., registered in EUDAMED on 21 May 2026 (Basic UDI-DI 42503371CONTHJ), cleared under FDA 510(k) K123234 on 5 Jul 2013 and listed in FDA GUDID since 30 Dec 2022 (UDI-DI 04250337117827), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K123234

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42503371CONTHJ Basic UDI-DI 04250337117827UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250337117827 UDI-DI Date30 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK123234 Date5 Jul 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 42503371CONTHJ registered 21 May 2026 Active
  • FDA 510(k) K123234 decided 5 Jul 2013 Active
  • FDA GUDID UDI-DI 04250337117827 listed 30 Dec 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K123234
  2. Listed FDA GUDID 04250337117827
  3. Registered EUDAMED 42503371CONTHJ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Intracs® em Sensor Tools Lid for DIN-Container EUDAMED
iLESSYS® GUDID
Generic name
Device sterilization/disinfection container, reusable
Device name
CESSYS® Dorsal Access Tray
Model / Ref / Catalog
TNC5828AL
Primary DI / UDI-DI
04250337117827
Basic UDI-DI
42503371CONTHJ
510(k) Number
FDA product code
KCT
EMDN code
S010401 Trays, baskets, tubs for sterilisation and their components
GMDN term
Device sterilization/disinfection container, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.6850
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Device sterilization/disinfection container, reusable

Cleared under the same submission (K123234)

and 8 more cleared under K123234

Similar devices in this category

Other devices filed under TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS.

Other devices from Joimax, Inc.

See all devices from Joimax, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)