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DuraDiagnost

by Philips Healthcare (Suzhou) Co., Ltd.

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 21 Oct 2026. What this means

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00884838064751 UDI-DI Date23 Sep 2016ListedStatusListed 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  • Withdrawn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

Generic Name
Stationary basic diagnostic x-ray system, digital
Model / Ref / Catalog
DuraDiagnost, 712214
Primary DI / UDI-DI
00884838064751
FDA Product Code
MQB, KPR
GMDN Term
Stationary basic diagnostic x-ray system, digital
Device Class
Class II
Regulation Number
892.1680
GUDID distribution status
Not in Commercial Distribution

Other devices from Philips Healthcare (Suzhou) Co., Ltd.

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