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NaviCam SB Capsule/Tether ES-US-3001

by Anx Robotica Corp.

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810164590039 UDI-DI Date9 Feb 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  • Withdrawn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
NaviCam SB Capsule/Tether
Generic Name
Video capsule endoscopy system capsule
Model / Ref / Catalog
ES-US-3001
Primary DI / UDI-DI
00810164590039
FDA Product Code
NEZ, QUN
GMDN Term
Video capsule endoscopy system capsule
Device Class
Class II
Regulation Number
876.1300, 876.1305
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

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