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Tsk Acecut Biopsy Needle

by TSK Laboratory, Japan United States EUDAMED

Ref ACE-161501CModel ACE-110751

EMDN A0102010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4571225300002U8 Basic UDI-DIDate14 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
ACE-110751, ACE-161501C
Primary DI / UDI-DI
04571225305219
Basic UDI-DI
4571225300002U8
EMDN Code
A0102010101 Shearing biopsy needles
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
JP-MF-000008485
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Tsk Laboratory, Japan

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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

Sources (1)

  • EUDAMED d7ad3969-cfd3-4dfe-b9fa-61ad91009ad9 61 fields · synced 22 Oct 2026