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AX000B7

by Steris Mexico, S. de R.L. de C.V.

Ref AX000B7Model Steam Sterilizer Accessories-600

AX000B7 is a device classified as Class I in the EU and Class II in the US made by Steris Mexico, S. de R.L. de C.V., registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 0724995MYSTMSLZ600AC2P), cleared under FDA 510(k) K232485 on 13 Sep 2023 (2 earlier submissions) and listed in FDA GUDID since 28 Oct 2020 (UDI-DI 00724995203023), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232485

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995MYSTMSLZ600AC2P Basic UDI-DI 00724995203023UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK232485 Date13 Sep 2023DecidedStatusActive
United StatesGUDID listing GUDID Number00724995203023 UDI-DI Date28 Oct 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0724995MYSTMSLZ600AC2P registered 23 Jul 2026 Active
  • FDA 510(k) K232485 decided 13 Sep 2023 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00724995203023 listed 28 Oct 2020 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K183410
  2. Listed FDA GUDID 00724995203023
  3. Cleared FDA 510(k) K211500
  4. Cleared FDA 510(k) K232485
  5. Registered EUDAMED 0724995MYSTMSLZ600AC2P

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  • Withdrawn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

Generic name
Sterilizer/disinfector rack
Device name
Steam Sterilizer Accessories-600
Model / Ref / Catalog
AX000B7, Steam Sterilizer Accessories-600
Primary DI / UDI-DI
00724995203023
Basic UDI-DI
0724995MYSTMSLZ600AC2P
510(k) Number
FDA product code
FLE
EMDN code
Z12011380 Cleaning, disinfection and sterilisation instruments - hardware accessories
GMDN term
Sterilizer/disinfector rack
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.6880
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Width — 24 Inch
Length — 36 Inch
Height — 36 Inch

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: Sterilizer/disinfector rack

Cleared under the same submission (K183410)

and 8 more cleared under K183410

Cleared under the same submission (K211500)

and 8 more cleared under K211500

Similar devices in this category

Other devices filed under CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Steris Mexico, S. de R.L. de C.V.

See all devices from Steris Mexico, S. de R.L. de C.V. →

Properties

  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)