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Tissue expander

by POLYTECH Health & Aesthetics GmbH Germany EUDAMED

Ref 51680-800, 50680-160, 50680-200, 51680-320, 51680-100, 51680-250, 50690-300, 50680-500, 50680-600, 50680-250, 50680-800, 51690-400, 51680-050, 50680-400, 51690-300, 50690-700, 51680-600Model Tissue expander

EMDN P900104

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04046745030502 Basic UDI-DIDate14 May 2025RegisteredStatusActive

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 22 Oct 2026

Device Name
Tissue expander
Model / Reference
Tissue expander, 51680-800, 50680-160, 50680-200, 51680-320, 51680-100, 51680-250, 50690-300, 50680-500, 50680-600, 50680-250, 50680-800, 51690-400, 51680-050, 50680-400, 51690-300, 50690-700, 51680-600
Primary DI / UDI-DI
04046745030502, 04046745031813, 04046745031394, 04046745030458, 04046745030410, 04046745030441, 04046745031431, 04046745031677, 04046745031684, 04046745031400, 04046745031820, 04046745030571, 04046745038683, 04046745031424, 04046745030564, 04046745030755, 04046745030489
Basic UDI-DI
B-04046745030502, B-04046745031813, B-04046745031394, B-04046745030458, B-04046745030410, B-04046745030441, B-04046745031431, B-04046745031677, B-04046745031684, B-04046745031400, B-04046745031820, B-04046745030571, B-04046745038683, B-04046745031424, B-04046745030564, B-04046745030755, B-04046745030489
EMDN Code
P900104, P900106
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000018836

Related devices

Category: Skin-port tissue expander

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 (17)

  • EUDAMED 95ca70b3-0773-44f8-a425-ff96e47889c3 61 fields · synced 22 Oct 2026
  • EUDAMED 04046745031813|B-04046745031813 61 fields · synced 16 May 2026
  • EUDAMED 04046745031394|B-04046745031394 61 fields · synced 16 May 2026
  • EUDAMED 04046745030458|B-04046745030458 61 fields · synced 16 May 2026
  • EUDAMED 04046745030410|B-04046745030410 61 fields · synced 16 May 2026
  • EUDAMED 04046745030441|B-04046745030441 61 fields · synced 16 May 2026
  • EUDAMED 04046745031431|B-04046745031431 61 fields · synced 16 May 2026
  • EUDAMED 04046745031677|B-04046745031677 61 fields · synced 17 May 2026
  • EUDAMED 04046745031684|B-04046745031684 61 fields · synced 17 May 2026
  • EUDAMED 04046745031400|B-04046745031400 61 fields · synced 17 May 2026
  • EUDAMED 04046745031820|B-04046745031820 61 fields · synced 17 May 2026
  • EUDAMED 04046745030571|B-04046745030571 61 fields · synced 18 May 2026
  • EUDAMED 04046745038683|B-04046745038683 61 fields · synced 18 May 2026
  • EUDAMED 04046745031424|B-04046745031424 61 fields · synced 18 May 2026
  • EUDAMED 04046745030564|B-04046745030564 61 fields · synced 18 May 2026
  • EUDAMED 04046745030755|B-04046745030755 61 fields · synced 18 May 2026
  • EUDAMED 04046745030489|B-04046745030489 61 fields · synced 18 May 2026