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RIKEN KEIKI Co., Ltd. FI-8000

by Riken Keiki Co., Ltd.

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 Number04571501890019 UDI-DI Date26 Mar 2025ListedStatusListed 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  • Withdrawn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
RIKEN KEIKI Co.,Ltd.
Generic Name
Anaesthesia vaporizer tester
Model / Ref / Catalog
FI-8000, PC3E-0421
Primary DI / UDI-DI
04571501890019
FDA Product Code
CBS
GMDN Term
Anaesthesia vaporizer tester
Device Class
Class II
Regulation Number
868.1620
GUDID distribution status
In Commercial Distribution

Other devices from Riken Keiki Co., Ltd.

Properties

  • Single Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: 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