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BIOexpress 469298

by BIOTRONIK SE & Co. KG

BIOexpress 469298 is a Class III device made by BIOTRONIK SE & Co. KG, listed in FDA GUDID since 20 Oct 2026 (UDI-DI 04035479177638), registry data as of 2 Nov 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04035479177638 UDI-DI Date20 Oct 2026ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
BIOexpress
Generic name
Cardiac pulse generator reader, professional
Model / Ref / Catalog
469298
Primary DI / UDI-DI
04035479177638
FDA product code
OSR
GMDN term
Cardiac pulse generator reader, professional
Device class
Class III
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code OSR (Pacemaker/icd/crt non-implanted components).

Other devices from BIOTRONIK SE & Co. KG

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)