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ThermoCool SF BDI35BBRT

by Biosense Webster Inc

Ref BDI35BBRT

ThermoCool SF BDI35BBRT is a Class III device made by Biosense Webster Inc, registered in EUDAMED on 21 May 2026 (Basic UDI-DI B-USMF000014219000031QF) and listed in FDA GUDID since 17 Sep 2014 (UDI-DI D-USMF000014219000031QF), withdrawn as of 25 Oct 2026.

Withdrawn Withdrawn in European Union.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

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/MDD EUDAMED NumberB-USMF000014219000031QF Basic UDI-DI D-USMF000014219000031QFUDI-DIDate21 May 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID NumberD-USMF000014219000031QF UDI-DI Date17 Sep 2014ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-USMF000014219000031QF registered 21 May 2026 Withdrawn
  • FDA GUDID UDI-DI D-USMF000014219000031QF listed 17 Sep 2014 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-USMF000014219000031QF
  2. Registered EUDAMED B-USMF000014219000031QF

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDD Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Thermocool Sf Bi-Directional Catheter EUDAMED
ThermoCool SF GUDID
Generic name
Cardiac radio-frequency ablation system catheter
Model / Ref / Catalog
BDI35BBRT
Primary DI / UDI-DI
D-USMF000014219000031QF EUDAMED
10846835002775 GUDID
Basic UDI-DI
B-USMF000014219000031QF
FDA product code
OAD
EMDN code
C020301 Arrhythmogenic foci radiofrequency ablation catheters
GMDN term
Cardiac radio-frequency ablation system catheter
Device class
Class III
EU registration type
Legacy device (under a directive)
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-USMF000014219000031QF
GUDID
10846835002775

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-USMF000014219000031QF; FDA GUDID lists 10846835002775), so their flags are not compared.

Related devices

Category: Cardiac radio-frequency ablation system catheter

Similar devices in this category

Other devices filed under CARDIAC TISSUE ABLATION DEVICES.

Other devices from Biosense Webster Inc

See all devices from Biosense Webster Inc →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)