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EMFACE controller BTL-785-7

by BTL Industries, Inc. 3 variants

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB108890APMMUS00 UDI-DI Date12 Oct 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  • Withdrawn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
EMFACE controller
Generic Name
Multi-modality hyperthermia system
Model / Reference
BTL-785-7
Primary DI / UDI-DI
B108890APMMUS00
FDA Product Code
NFO, NUW, GEI, PBX
GMDN Term
Multi-modality hyperthermia system
Device Class
Class II
Regulation Number
882.5890, 890.5850, 878.4400
GUDID distribution status
In Commercial Distribution

Other devices from BTL Industries, Inc.

See all devices from BTL Industries, Inc. →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

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