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Aed Endopro® Primo Series Camera EP2050HD

by National Advanced Endoscopy Devices, Inc. 2 variants

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 Number00848657077729 UDI-DI Date25 Sep 2025ListedStatusListed 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  • Withdrawn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
Aed Endopro® Primo Series Camera
Generic Name
Endoscope video camera
Model / Reference
EP2050HD
Primary DI / UDI-DI
00848657077729
FDA Product Code
FWF, KQM
GMDN Term
Endoscope video camera
Device Class
Class I
Regulation Number
878.4160
GUDID distribution status
In Commercial Distribution

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Properties

  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number

Other properties (10)

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