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Balloon2 MH-525

by Olympus Medical Systems Corporation 2 variants

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 Number04953170055546 UDI-DI Date12 Oct 2017ListedStatusListed 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  • Withdrawn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
Balloon2
Generic Name
Ultrasound endoscope balloon, Hevea-latex
Model / Reference
MH-525
Primary DI / UDI-DI
04953170055546
FDA Product Code
ITX
GMDN Term
Ultrasound endoscope balloon, Hevea-latex
Device Class
Class II
Regulation Number
892.1570
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Ethylene Oxide

Other devices from Olympus Medical Systems Corporation

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Properties

  • Single Use
  • Contains Latex
  • Prescription Use
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No