Skip to content

Kösemed

by Kösemed Ortopedi̇ San. Ve Ti̇c. İth. İhr. A.Ş. 1,000+ variants

Ref 625-04

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-86820355013295R Basic UDI-DI D-86820355013295RUDI-DIDate9 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Protez Sütyeni 80
Model / Reference
625-04
Primary DI / UDI-DI
D-86820355013295R
Basic UDI-DI
B-86820355013295R
EMDN Code
P0601010299 Breast implants, round, made of silicone - other
Device Class
Class I
EU 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

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