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MEME PROTEZİ ( MASTEKTOMİ AMELİYATI SONRASI ASKILIKLI) No:115

by Abc Tip Sağlik Spor Malz. Teks. Turz. İnş. San. Ve Ti̇c. Ltd. Şti̇.

Ref HB 5285 115Model CORSET

Active European Union

CE MDR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86978888KRSGE Basic UDI-DI 08697888835521UDI-DIDate1 Jul 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Korse
Model / Reference
CORSET, HB 5285 115
Primary DI / UDI-DI
08697888835521
Basic UDI-DI
86978888KRSGE
Direct Marketing DI
08697888835521
EMDN Code
Y063018 External breast prostheses
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000035839

Other devices from Abc Tip Sağlik Spor Malz. Teks. Turz. İnş. San. Ve Ti̇c. Ltd. Şti̇.

See all devices from Abc Tip Sağlik Spor Malz. Teks. Turz. İnş. San. Ve Ti̇c. Ltd. Şti̇. →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • 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