Skip to content

Polydioxanone Suture

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

Ref SC25090510WModel mono

EMDN H010101010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800060822855 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  • Withdrawn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European Union — CE/MDD Withdrawn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 23 Oct 2026

Device Name
Polydioxanone Suture
Model / Reference
mono, SC25090510W
Primary DI / UDI-DI
08800060822855
Basic UDI-DI
B-08800060822855
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 f00d4847-f9d1-45e6-85fe-5cf47db3ee66 61 fields · synced 23 Oct 2026