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2 x K-Pack II Needle 1 x Terumo Syringe

by Terumo Europe N.V. 3 variants

Ref KIT-S02K2125E

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 Number5413206KITSSKNWJ Basic UDI-DI 05413206223534UDI-DIDate10 Oct 2024RegisteredStatusActive

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  • Withdrawn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

Model / Reference
KIT-S02K2125E
Primary DI / UDI-DI
05413206223534
Basic UDI-DI
5413206KITSSKNWJ
EMDN Code
A0101010102, A020102020102
Device Class
Class IIa
Medical Purpose
Depends on the components of the kit pack. The devices for general application are put together in the kit pack (procedure pack) on the request of a PS customer, within their intended use and within the limits of use specified by their original manufacturer. The specific medical purpose is defined by the customer for which the kit pack is developed, while respecting the limits of use as specified by the manufacturers of the components.

Manufacturer details

EUDAMED SRN
BE-PR-000001431

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Properties

  • Sterile