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Amimon MD52 Tx device - MDWL2_B1P1TX

by Rocoto Inc.

Amimon MD52 Tx device - MDWL2_B1P1TX is a Class I device made by Rocoto Inc., listed in FDA GUDID since 24 Jun 2025 (UDI-DI 00860014100666), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860014100666 UDI-DI Date24 Jun 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Amimon
Generic name
Medical image management system
Model / Ref / Catalog
MD52 Tx device - MDWL2_B1P1TX, MDWL2_B1P1TX
Primary DI / UDI-DI
00860014100666
FDA product code
OUG
GMDN term
Medical image management system
Device class
Class I
Regulation number
880.6310
GUDID distribution status
In Commercial Distribution

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Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)