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ROGIN Apex Locator APEX-R

by Shenzhen Rogin Medical Co., Ltd

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 Number06972214519071 UDI-DI Date14 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  • Withdrawn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
Rogin
Generic Name
Endodontic apex locator
Model / Reference
Apex Locator APEX-R
Primary DI / UDI-DI
06972214519071
FDA Product Code
LQY
GMDN Term
Endodontic apex locator
Device Class
U
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Shenzhen Rogin Medical Co., Ltd

See all devices from Shenzhen Rogin Medical Co., Ltd →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No