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BioHealx Anal Fistula Device BH201X1

by Signum Surgical Limited

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number05391546930001 UDI-DI Date25 Jun 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
BioHealx Anal Fistula Device
Generic Name
Anal fistula closure coil
Model / Reference
BH201X1
Primary DI / UDI-DI
05391546930001
De Novo Number
FDA Product Code
QML
GMDN Term
Anal fistula closure coil
Device Class
Class II
Regulation Number
878.4835
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Related devices

Category: Anal fistula closure coil

Other devices from Signum Surgical Limited

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No