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Newgyn

by Mastelli S.r.l. Italy EUDAMED

Ref DDM42BL20XS

EMDN P900402

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-8053303261441DDM42EB Basic UDI-DIDate24 Jan 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 24 Oct 2026

Model / Reference
DDM42BL20XS
Primary DI / UDI-DI
D-8053303261441DDM42EB
Basic UDI-DI
B-8053303261441DDM42EB
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000023613

Other devices from Mastelli S.r.l.

See all devices from Mastelli S.r.l. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
  • Animal Tissues
Other properties (8)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 534c5cc2-aa60-4fa7-bae9-b30076768166 61 fields · synced 24 Oct 2026