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BF853

by Steris Corporation

Ref BF853Model Urology Package

BF853 is a Class I device made by Steris Corporation, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI 0724995MGUROLOGYPKGLT) and listed in FDA GUDID since 23 Apr 2021 (UDI-DI 00724995164591), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995MGUROLOGYPKGLT Basic UDI-DI 00724995164591UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995164591 UDI-DI Date23 Apr 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0724995MGUROLOGYPKGLT registered 1 Oct 2026 Active
  • FDA GUDID UDI-DI 00724995164591 listed 23 Apr 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00724995164591
  2. Registered EUDAMED 0724995MGUROLOGYPKGLT

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  • Withdrawn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

Generic name
Universal operating table top
Model / Ref / Catalog
BF853, Urology Package
Primary DI / UDI-DI
00724995164591
Basic UDI-DI
0724995MGUROLOGYPKGLT
FDA product code
FQO
EMDN code
Z12011299 Patient positioning instruments – other
GMDN term
Universal operating table top
Device class
Class I
Regulation number
878.4960
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Related devices

Category: Universal operating table top

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS – OTHER.

Other devices from Steris Corporation

See all devices from Steris Corporation →

Properties

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