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Polydioxanone Suture

by AHEALTHZ MEDICAL PRECISION Co., Ltd. South Korea EUDAMED

Ref SC26050710RModel mono

EMDN H010101010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800060822657 Basic UDI-DIDate1 Jul 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/MDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Polydioxanone Suture
Model / Reference
mono, SC26050710R
Primary DI / UDI-DI
08800060822657
Basic UDI-DI
B-08800060822657
EMDN Code
H010101010101 Polydioxanone monofilament with needle for open surgery
Device Class
Class III

Manufacturer details

EUDAMED SRN
KR-MF-000030190
Authorised representative
Javitech Consulting GmbH DE-AR-000045915

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED e2ad653e-3f71-4125-9cd7-3867dcf6c321 61 fields · synced 24 Oct 2026