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Da:all (P2B2390L-70160)

by Meta Biomed Co., Ltd. South Korea EUDAMED

Model Sterile Absorbable Polydioxanone Suture with Needle, Dyed or Undyed EMDN H0101010299

Regulatory status

as of 25 Oct 2026

Withdrawn since 18 May 2026. The authorization below is no longer in force.

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880638782001KS Basic UDI-DIDate22 Jan 2025RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Withdrawn

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • M.2025.MDR.1058-1 Withdrawn

    Technical documentation EU MDR

    Notified body
    UDEM Adriatic d.o.o. 2696
    Issued
    14 Jan 2025
    Expires
    13 Jan 2028
    Reason
    Other

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
Sterile Absorbable Polydioxanone Suture with Needle, Dyed or Undyed
Primary DI / UDI-DI
08806387849452
Basic UDI-DI
880638782001KS
EMDN Code
H0101010299 Synthetic absorbable multifilament sutures - other
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000009681
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from Meta Biomed Co., Ltd.

See all devices from Meta Biomed Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (11)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED d3cd47a1-93a3-4ddd-9fe3-ba76928b5df2 61 fields · synced 25 Oct 2026