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Newest

by Mastelli S.r.l. Italy EUDAMED

Ref RDM60BLS20XS

EMDN P900402

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805330326RDM604J Basic UDI-DIDate8 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • EPT 0477.MDR.26/6119 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 0477
    Issued
    30 Mar 2026
    Expires
    29 Mar 2031
  • EPT 0477.MDR.26/6120 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0477
    Issued
    30 Mar 2026
    Expires
    10 Jul 2030

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
RDM60BLS20XS
Primary DI / UDI-DI
08053303261960
Basic UDI-DI
805330326RDM604J
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 (10)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 08053303261960|805330326RDM604J 61 fields · synced 24 Oct 2026