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ROGIN Endo Motor E-LITE PRO

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 Number06972214519057 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  • Withdrawn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
Dental surgical power tool motorized handpiece/set, electric
Model / Reference
Endo Motor E-LITE PRO
Primary DI / UDI-DI
06972214519057
FDA Product Code
EKX
GMDN Term
Dental surgical power tool motorized handpiece/set, electric
Device Class
Class I
Regulation Number
872.4200
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