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STERiJECT

by TSK Laboratory, Japan United States EUDAMED

Ref PRC-25013IModel PRE-21025

EMDN A0199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4571225300011U9 Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Tsk Hypodermic Needle
Model / Reference
PRE-21025, PRC-25013I
Primary DI / UDI-DI
04571225313313
Basic UDI-DI
4571225300011U9
EMDN Code
A0199 Needles - other
Device Class
Class IIa
Market of Registration
France

Manufacturer details

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

Other devices from Tsk Laboratory, Japan

See all devices from Tsk Laboratory, Japan →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Administering Medicine
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 04571225313313|4571225300011U9 61 fields · synced 24 Oct 2026