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STERiJECT

by TSK Laboratory, Japan 36 variants

Ref HPC-31013EModel PRE-21025

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4571225300011U9 Basic UDI-DI 04571225317618UDI-DIDate21 May 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Tsk Hypodermic Needle
Model / Reference
PRE-21025, HPC-31013E
Primary DI / UDI-DI
04571225317618
Basic UDI-DI
4571225300011U9
EMDN Code
A0199 Needles - other
Device Class
Class IIa
EU market of registration
France

Manufacturer details

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

Related devices

Category: Hypodermic needle, single-use

Other devices from Tsk Laboratory, Japan

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Properties

  • 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