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Proteza Piersi Maxima

by Przedsiębiorstwo Obrotu I Fabrykacji Artykułów Medycznych Pofam- Poznań Spółka Z Ograniczoną Odpowiedzialnością 325 variants

Ref 7004-L-LEFT-T03

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 22 Oct 2026. What this means

Overview

The Proteza Piersi Maxima is a Class I medical device that offers a unique and innovative solution for breast prostheses. With its advanced technology and sleek design, this device provides a comfortable and natural look for patients undergoing breast reconstruction.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number59027066BREASTPROSTHESM4 Basic UDI-DI 05902706672039UDI-DIDate26 Jan 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  • Withdrawn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

Model / Reference
7004-L-LEFT-T03
Primary DI / UDI-DI
05902706672039
Basic UDI-DI
59027066BREASTPROSTHESM4
EMDN Code
Y0699 External prostheses and orthoses - other
Device Class
Class I
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000050850

Other devices from Przedsiębiorstwo Obrotu I Fabrykacji Artykułów Medycznych Pofam- Poznań Spółka Z Ograniczoną Odpowiedzialnością

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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