Skip to content

Proteza Piersi Maxima

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

Ref 8005-T18, 4001-T0, 7004-L-LEWA-T08, 7004-LEWA-T09, 4001-W-T06, 4001-U-T0, 4001-W-T04, 8005-E-T12, 8005-T04, 9006-U-T07, 8005-L-T20, 4001-U-T12, 7004-L-PRAWA-T02, 4001-L-T07, 8005-L-T11, 7004-LEWA-T05, 9006-L-T07, 4001-U-T06, 8005-E-T02, 4001-L-T0, 8005-T19, 7004-L-LEWA-T11, 8005-T02, 9006-L-T0, 8005-T12, 4001-L-T17, 7004-L-PRAWA-T09, 7004-C-LEWA-T08, 7004-L-LEWA-T05, 7004-C-PRAWA-T08, 8005-T05, 9006-T02, 4001-U-T16, 7004-C-LEWA-T05, 8005-E-T09, 4001-T03, 7004-LEWA-T07, 4001-W-T16, 7004-PRAWA-T05, 8005-T01, 8005-E-T08, 9006-U-T03, 4001-W-T10, 4001-T15, 7004-LEWA-T12, 7004-PRAWA-T08, 9006-T09, 7004-LEWA-T08, 7004-C-LEWA-T14, 9006-T10, 4001-L-T05

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number59027066BREASTPROSTHESM4 Basic UDI-DI Date26 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  • Withdrawn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
8005-T18, 4001-T0, 7004-L-LEWA-T08, 7004-LEWA-T09, 4001-W-T06, 4001-U-T0, 4001-W-T04, 8005-E-T12, 8005-T04, 9006-U-T07, 8005-L-T20, 4001-U-T12, 7004-L-PRAWA-T02, 4001-L-T07, 8005-L-T11, 7004-LEWA-T05, 9006-L-T07, 4001-U-T06, 8005-E-T02, 4001-L-T0, 8005-T19, 7004-L-LEWA-T11, 8005-T02, 9006-L-T0, 8005-T12, 4001-L-T17, 7004-L-PRAWA-T09, 7004-C-LEWA-T08, 7004-L-LEWA-T05, 7004-C-PRAWA-T08, 8005-T05, 9006-T02, 4001-U-T16, 7004-C-LEWA-T05, 8005-E-T09, 4001-T03, 7004-LEWA-T07, 4001-W-T16, 7004-PRAWA-T05, 8005-T01, 8005-E-T08, 9006-U-T03, 4001-W-T10, 4001-T15, 7004-LEWA-T12, 7004-PRAWA-T08, 9006-T09, 7004-LEWA-T08, 7004-C-LEWA-T14, 9006-T10, 4001-L-T05
Primary DI / UDI-DI
05902706681185, 05904125001001, 05904125000745, 05904125000103, 05904125002015, 05904125001780, 05904125001995, 05904125002251, 05904125001223, 05904125002589, 05904125001599, 05904125001902, 05904125000851, 05904125001674, 05904125001506, 05904125000066, 05904125002923, 05904125001841, 05904125002152, 05904125001605, 05904125001377, 05904125000776, 05904125001209, 05904125002855, 05904125001308, 05904125001773, 05904125000929, 05904125000424, 05904125000714, 05904125000585, 05904125001230, 05904125002367, 05904125001940, 05904125000394, 05904125002220, 05904125001032, 05904125000080, 05904125002114, 05904125000233, 05904125001193, 05904125002213, 05904125002541, 05904125002053, 05904125001155, 05904125000134, 05904125000264, 05904125002435, 05904125000097, 05904125000486, 05904125002442, 05904125001650
Basic UDI-DI
59027066BREASTPROSTHESM4, 59041250BREASTPROSTHES73
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

See all devices from Przedsiębiorstwo Obrotu I Fabrykacji Artykułów Medycznych Pofam- Poznań Spółka Z Ograniczoną Odpowiedzialnością →

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