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Breast expander

by POLYTECH Health & Aesthetics GmbH Germany EUDAMED

Ref 42642-600Model Breast expander

EMDN P060299

Overview

A breast expander device is a medical device designed to expand and support the breasts before surgery, helping to improve breast volume and appearance. It typically consists of metal or plastic components that are attached to the skin, which can be filled with saline solution. The device works by using compression to push the tissue upward and outward, providing temporary support until the breast is healed.

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04046745127875 Basic UDI-DIDate29 May 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 23 Oct 2026

Model / Reference
Breast expander, 42642-600
Primary DI / UDI-DI
04046745127875
Basic UDI-DI
B-04046745127875
EMDN Code
P060299 Breast implants, expander - other
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 9955aa5e-b776-4b6b-abea-f45785157775 61 fields · synced 23 Oct 2026