Skip to content

Tessys® TITSU5324752

by Joimax, Inc.

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

Ref TITSU5324752

Tessys® TITSU5324752 is a Class I device made by Joimax, Inc., registered in EUDAMED on 21 May 2026 (Basic UDI-DI 42503371CONTHJ) and listed in FDA GUDID since 30 Dec 2022 (UDI-DI 04250337114574), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42503371CONTHJ Basic UDI-DI 04250337114574UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250337114574 UDI-DI Date30 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42503371CONTHJ registered 21 May 2026 Active
  • FDA GUDID UDI-DI 04250337114574 listed 30 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250337114574
  2. Registered EUDAMED 42503371CONTHJ

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
TESSYS® Isee Sterilization Tray for Instruments EUDAMED
Tessys® GUDID
Generic name
Instrument tray, reusable
Device name
CESSYS® Dorsal Access Tray
Model / Ref / Catalog
TITSU5324752
Primary DI / UDI-DI
04250337114574
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
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Instrument tray, reusable

Similar devices in this category

Other devices filed under DEVICES FOR STERILISATION AND PACKAGING (EXCLUDING CAT. D - Z).

Other devices from Joimax, Inc.

See all devices from Joimax, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)