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BEXCORE Breast Biopsy Needle BXC140

by Medical Park Co., Ltd. EUDAMEDGUDID

Active European Union

Ref BXC140, BXC145, BXCW140, BXCW145

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800025901601 UDI-DIDate1 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number88000259002NU Basic UDI-DIDate4 Nov 2024RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR 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 Needle EUDAMED
BEXCORE Breast Biopsy Needle GUDID
Generic Name
Side-notch biopsy gun handpiece/needle
Device Name
VABB(Vacuum-Assisted Breast Biopsy) Needle
Model / Reference
BXC140, BXC145, BXCW140, BXCW145
Primary DI / UDI-DI
08800025901601
Basic UDI-DI
88000259002NU
FDA Product Code
FCG
EMDN Code
A01020199 Needles and kits for histological and cytological biopsy of soft tissues - other
GMDN Term
Side-notch biopsy gun handpiece/needle
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
BXC140, BXC145, BXCW140, BXCW145
GUDID
BXC140
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Medical Park Co., Ltd.

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

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: 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
  • Serial Number: No