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Minder® Implant P1650482

by Epi-Minder Pty, 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 Number00840336500085 UDI-DIDate1 Dec 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  • Withdrawn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
Minder® Implant
Generic Name
Electroencephalographic monitoring system
Model / Ref / Catalog
P1650482
Primary DI / UDI-DI
00840336500085
FDA Product Code
SEM
GMDN Term
Electroencephalographic monitoring system
Device Class
Class II
Regulation Number
882.1360
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

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Properties

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

Other properties (8)

  • 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