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BEXCORE Breast Biopsy System BXS100

by Medical Park Co., Ltd. EUDAMEDGUDID

Active European Union

Ref BXS100

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800025901151 UDI-DIDate1 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-08800025901151 Basic UDI-DIDate7 Nov 2024RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Bexcore System EUDAMED
BEXCORE Breast Biopsy System GUDID
Generic Name
Mammographic stereotactic biopsy system
Device Name
VABB(Vacuum-Assisted Breast Biopsy) System
Model / Reference
BXS100
Primary DI / UDI-DI
08800025901151
Basic UDI-DI
B-08800025901151
FDA Product Code
KNW
EMDN Code
Z120105 Surgical medical aspirators
GMDN Term
Mammographic stereotactic biopsy system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1075
Market of Registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

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Properties

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

Other properties (17)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No