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Kösemed

by Kösemed Ortopedi̇ San. Ve Ti̇c. İth. İhr. A.Ş. Türkiye EUDAMED

Ref 625-08

EMDN P0601010299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-86820355013675Z Basic UDI-DIDate9 Apr 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
Protez Sütyeni 100
Model / Reference
625-08
Primary DI / UDI-DI
D-86820355013675Z
Basic UDI-DI
B-86820355013675Z
EMDN Code
P0601010299 Breast implants, round, made of silicone - other
Device Class
Class I
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000021022

Other devices from Kösemed Ortopedi̇ San. Ve Ti̇c. İth. İhr. A.Ş.

See all devices from Kösemed Ortopedi̇ San. Ve Ti̇c. İth. İhr. A.Ş. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • 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 babbbff1-63d8-4f2e-a3d8-593d9f3868ed 61 fields · synced 24 Oct 2026