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BF539

by Steris Corporation

Part of a family of 6 devices: see the family page

Ref BF539Model Traction Device

BF539 is a Class I device made by Steris Corporation, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI 0724995MGTRACTIONDEVBA) and listed in FDA GUDID since 23 Apr 2021 (UDI-DI 00724995165390), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995MGTRACTIONDEVBA Basic UDI-DI 00724995165390UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995165390 UDI-DI Date23 Apr 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0724995MGTRACTIONDEVBA registered 1 Oct 2026 Active
  • FDA GUDID UDI-DI 00724995165390 listed 23 Apr 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00724995165390
  2. Registered EUDAMED 0724995MGTRACTIONDEVBA

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  • Withdrawn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
Traction boot
Device name
Traction Device
Model / Ref / Catalog
BF539, Traction Device
Primary DI / UDI-DI
00724995165390 EUDAMED
10724995165397 GUDID
Basic UDI-DI
0724995MGTRACTIONDEVBA
Unit of use DI
10724995165397
FDA product code
HST
EMDN code
Z12130285 Orthopaedic traction instruments - consumables
GMDN term
Traction boot
Device class
Class I
Regulation number
888.5850
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00724995165390
GUDID
10724995165397

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00724995165390; FDA GUDID lists 10724995165397), so their flags are not compared.

Related devices

Category: Traction boot

Similar devices in this category

Other devices filed under ORTHOPAEDIC TRACTION INSTRUMENTS - CONSUMABLES.

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)