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DistricAth Ti/PSU ELIES PM P2, 8

by Districlass Medical SA 8 variants

Ref KP6122830, KP6122837, KP6122864, KP6122845, KP6122825, KP6122844, KP6122824, KP6122812, KP6122841

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 Number3665642Art.22MDRTi/PSUTZ Basic UDI-DI Date23 Oct 2025RegisteredStatusActive

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  • Withdrawn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
DistricAth Ti/PSU
Model / Reference
KP6122830, KP6122837, KP6122864, KP6122845, KP6122825, KP6122844, KP6122824, KP6122812, KP6122841
Primary DI / UDI-DI
03665642012001, 03665642012032, 03665642012209, 03665642032191, 03665642032078, 03665642012094, 03665642011981, 03665642011929, 03665642012063
Basic UDI-DI
3665642Art.22MDRTi/PSUTZ
EMDN Code
C01020401 Subcutaneous implantable venous access port systems, single-chamber
Device Class
Class III
Medical Purpose
Les chambres à cathéter implantables DistricAth® sont des dispositifs médicaux permettant un accès transcutané au système vasculaire intraveineux dans le cadre de traitements itératifs et de longue durée d’un patient : Chimiothérapie, antibiothérapie, nutrition parentérale, prélèvement ou injection de produits sanguins.

Manufacturer details

EUDAMED SRN
FR-PR-000009488

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Properties

  • Sterile