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Recirculator 8.0

by Eight Medical International B.V.

Listed FDA GUDID listing, not in commercial distribution

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 Number08719992086009 UDI-DI Date10 Apr 2020ListedStatusListed GUDID: not 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  • Withdrawn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
Recirculator
Generic Name
Extravascular-circulation hyperthermia system applicator, intracorporeal
Model / Reference
8.0
Primary DI / UDI-DI
08719992086009
FDA Product Code
LGZ
GMDN Term
Extravascular-circulation hyperthermia system applicator, intracorporeal
Device Class
Class II
Regulation Number
880.5725
GUDID distribution status
Not in Commercial Distribution

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

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