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Set Dialyse Peritoneale

by Hemodia SAS

Ref 8127_B

Active European Union

CE MDR CE MDD

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-03661379202524 Basic UDI-DI Date18 Aug 2026RegisteredStatusActive
European UnionCE/MDD NumberB-03661379202524 Basic UDI-DI Date18 Aug 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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Device Name
Set De Soin
Assemblage DIALYSE STE
Model / Reference
8127_B
Primary DI / UDI-DI
03661379202524, 03661379279045
Basic UDI-DI
B-03661379202524, 3661379ASS13DIA01F5
EMDN Code
F0303 Haemodialysis kits
Device Class
Class I
EU market of registration
France
Medical Purpose
Les assemblages de la gamme ‘Dialyse’ sont destinés à : Être utilisés lors du branchement / débranchement ou changement des lignes de dialyse et lors des soins des personnes dialysées : - Réaliser la connexion et déconnexion des lignes à sang en hémodialyse par cathéter ou par fistule au générateur de dialyse. - Réaliser le branchement / débranchement des poches en dialyse péritonéale (DPCA). - Procéder aux soins des personnes dialysées notamment à l’entretien des sites de cathéter (péritonéale et cathéters d’hémodialyse).

Manufacturer details

EUDAMED SRN
FR-MF-000007191

Other devices from Hemodia SAS

See all devices from Hemodia SAS →

Properties

  • Sterile
  • Contains Latex

Other properties (9)

  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No