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Rivacor Sky HF-T QP 481990

by BIOTRONIK SE & Co. KG

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04035479182854 UDI-DI Date20 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Rivacor Sky HF-T QP
Generic Name
Cardiac resynchronization therapy implantable defibrillator
Model / Ref / Catalog
481990
Primary DI / UDI-DI
04035479182854
FDA Product Code
NIK
GMDN Term
Cardiac resynchronization therapy implantable defibrillator
Device Class
Class III
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Manufacturing Date: No