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ATEC Breast Biopsy and Excision System Handpiece

by Hologic, Inc. EUDAMEDGUDID

Active European Union and United States

Ref ATEC 1209-20

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number54200455ATECEVIVAHANDPCHA Basic UDI-DIDate4 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number15420045504905 UDI-DIDate26 Jul 2016ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

4 recalls · FDA

    • Terminated Z-2285-2010 FDA Unclassified (pre-2012) initiated 11 Aug 2010

    The firm received a customer complaint that the a device labeled as ATEC 0912-12 was actually ATEC 0912-20.

    • Terminated Z-1160-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010

    The product is labeled as ATEC0909-12 but it actually contains 0909-20.

    • Terminated Z-0275-2009 FDA Unclassified (pre-2012) initiated 22 Sep 2008

    The distal tip of the needle may become detached and remain in the patient, requiring surgical removal.

    • Terminated Z-0362-2007 FDA Unclassified (pre-2012) initiated 15 Dec 2006

    The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle.

Specification

EUDAMED · GUDID

Trade Name
ATEC Breast Biopsy and Excision System Handpiece EUDAMED
Atec 1209-20 GUDID
Generic Name
Side-notch biopsy gun handpiece/needle
Device Name
ATEC and Eviva Breast Biopsy and Excision System - Biopsy Devices and Introducers
Model / Ref / Catalog
ATEC 1209-20
Primary DI / UDI-DI
15420045504905
Basic UDI-DI
54200455ATECEVIVAHANDPCHA
Direct Marketing DI
15420045504905
510(k) Number
FDA Product Code
KNW
EMDN Code
A010299 Biopsy needles and kits - other
GMDN Term
Side-notch biopsy gun handpiece/needle
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1075
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000045852
Authorised representative
Hologic BV BE-AR-000000127

Other devices from Hologic

See all devices from Hologic →

Properties

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

Other properties (19)

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