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OPTIMA İKİ KANALLI UZUN SÜRELİ KATETER SETİ 14Fr 28 Cm DÜZ

by DLR Medikal

Ref DDLC-1428-SModel LONG TERM HEMODIALYSIS CATHETER, SETS AND ACCESSORIES

Active European Union

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

Overview

Optima Dual Lumen Long Term Catheter Set 14Fr 28 Cm Straight is a comprehensive medical device for patients requiring long-term hemodialysis catheters. This multi-component device consists of a lumenergic catheter, a connector, and a sheath, providing reliable and efficient access to the dialysis site.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08681299207589 Basic UDI-DI 08681299207589UDI-DIDate28 Apr 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
LONG TERM HEMODIALYSIS CATHETER, SETS AND ACCESSORIES, DDLC-1428-S
Primary DI / UDI-DI
08681299207589
Basic UDI-DI
B-08681299207589
EMDN Code
F900202 Permanent hemodialysis catheters and kits
Device Class
Class III
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000024447

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Properties

  • Sterile
  • Implantable

Other properties (9)

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