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Artemis 2.0

by Eigen Health Services LLC

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860009734814 UDI-DIDate28 Jan 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  • Withdrawn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
Artemis
Generic Name
Rectal ultrasound navigational image processor
Model / Ref / Catalog
2.0, 900-20000-00
Primary DI / UDI-DI
00860009734814
FDA Product Code
QTZ, GEH
GMDN Term
Rectal ultrasound navigational image processor
Device Class
Class II
Regulation Number
892.2050, 878.4350
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Eigen Health Services LLC

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