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MammoScape 1.0.x

by MeVis BreastCare GmbH & Co. KG

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 Number04262459510011 UDI-DI Date7 Nov 2024ListedStatusListed 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  • Withdrawn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
MammoScape
Generic Name
Diagnostic x-ray digital imaging system workstation application software
Model / Reference
1.0.x
Primary DI / UDI-DI
04262459510011
FDA Product Code
LMD
GMDN Term
Diagnostic x-ray digital imaging system workstation application software
Device Class
Class I
Regulation Number
892.2020
GUDID distribution status
Not in Commercial Distribution

Properties

  • Premarket Exempt
  • Lot / Batch Number

Other properties (12)

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