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miraDry MD4000-HP

by miraDry Inc.

miraDry MD4000-HP is an electrosurgical system generator (FDA Class II) made by miraDry Inc., listed in FDA GUDID since 30 Sep 2016 (UDI-DI 00853419006015), registry data as of 8 Nov 2026.

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

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00853419006015 UDI-DI Date30 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
miraDry
Generic name
Electrosurgical system generator
Model / Ref / Catalog
MD4000-HP
Primary DI / UDI-DI
00853419006015
FDA product code
MWY, NEY, OUB
GMDN term
Electrosurgical system generator
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrosurgical system generator

Similar devices in this category

Other devices filed under Electrosurgical system generator.

Other devices from miraDry Inc.

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)