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MireMed PEN TIPS 02-3204

by Sandstone Medical (Suzhou) Inc.

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 Number16972857296350 UDI-DI Date30 Apr 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  • Withdrawn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
MireMed PEN TIPS
Generic Name
Autoinjector needle
Model / Reference
02-3204
Primary DI / UDI-DI
16972857296350
FDA Product Code
FMI
GMDN Term
Autoinjector needle
Device Class
Class II
Regulation Number
880.5570
GUDID distribution status
In Commercial Distribution

Other devices from Sandstone Medical (Suzhou) Inc.

See all devices from Sandstone Medical (Suzhou) Inc. →

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No