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E-PEN Powered Microneedle Device

by Bomtech Electronics Co., Ltd. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800016000443 UDI-DIDate29 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
E-Pen
Generic Name
Cosmetic micro-needling electronic handpiece, professional
Model / Reference
Powered Microneedle Device
Primary DI / UDI-DI
08800016000443
510(k) Number
FDA Product Code
QAI
GMDN Term
Cosmetic micro-needling electronic handpiece, professional
Device Class
Class II
Regulation Number
878.4430
GUDID distribution status
In Commercial Distribution

Other devices from Bomtech Electronics Co., Ltd.

Properties

  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • 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
  • Premarket Exempt: No
  • Expiration Date: No