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Mammary implant

by POLYTECH Health & Aesthetics GmbH Germany EUDAMED

Ref 10626-305Model Mammary implant EMDN P0601010201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04046745050814 Basic UDI-DIDate29 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Mammary implant
Model / Reference
Mammary implant, 10626-305
Primary DI / UDI-DI
04046745050814
Basic UDI-DI
B-04046745050814
EMDN Code
P0601010201 Breast implants, round, made of silicone, with smooth surface
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000018836

Other devices from POLYTECH Health & Aesthetics GmbH

See all devices from POLYTECH Health & Aesthetics GmbH →

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 04046745050814|B-04046745050814 61 fields · synced 24 Oct 2026