Skip to content

BEXCORE Breast Biopsy System Bexcore System-BXS100

by Medical Park Co., Ltd. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800025902059 UDI-DIDate1 Jun 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  • Withdrawn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
BEXCORE Breast Biopsy System
Generic Name
Mammographic stereotactic biopsy system
Model / Reference
Bexcore System-BXS100
Primary DI / UDI-DI
08800025902059
FDA Product Code
KNW
GMDN Term
Mammographic stereotactic biopsy system
Device Class
Class II
Regulation Number
876.1075
GUDID distribution status
In Commercial Distribution

Other devices from Medical Park Co., Ltd.

See all devices from Medical Park Co., Ltd. →

Properties

  • Premarket Exempt
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (10)

  • 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
  • Lot / Batch Number: No