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FD009

by Corporation Steris Canada

Ref FD009Model Washer Disinfector Rack

FD009 is a device classified as Class I in the EU and Class II in the US made by Corporation Steris Canada, registered in EUDAMED on 25 Jun 2026 (Basic UDI-DI B-00724995150884) and listed in FDA GUDID since 13 Sep 2016 (UDI-DI 00724995150884), active as of 22 Oct 2026.

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

CE MDD

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00724995150884 Basic UDI-DI 00724995150884UDI-DIDate25 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995150884 UDI-DI Date13 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00724995150884 registered 25 Jun 2026 Active
  • FDA GUDID UDI-DI 00724995150884 listed 13 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00724995150884
  2. Registered EUDAMED B-00724995150884

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Sterilizer/disinfector rack
Device name
Washer Disinfector Rack
Model / Ref / Catalog
FD009, Washer Disinfector Rack
Primary DI / UDI-DI
00724995150884
Basic UDI-DI
B-00724995150884
FDA product code
MEC
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
880.6992
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

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

Similar devices in this category

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

Other devices from Corporation Steris Canada

See all devices from Corporation Steris Canada →

Properties

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