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Polydioxanone Suture

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

Ref SC30025610NModel mono

EMDN H010101010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800060823838 Basic UDI-DIDate30 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Polydioxanone Suture
Model / Reference
mono, SC30025610N
Primary DI / UDI-DI
08800060823838
Basic UDI-DI
B-08800060823838
EMDN Code
H010101010101 Polydioxanone monofilament with needle for open surgery
Device Class
Class III
Market of Registration
Hungary

Manufacturer details

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

Other devices from AHEALTHZ MEDICAL PRECISION Co., Ltd.

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 08800060823838|B-08800060823838 61 fields · synced 24 Oct 2026