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PROSHAPE TS Ø 3, 8 h 9, 5 HYBRID

by Prodent Italia S.r.l. EUDAMED

Active European Union

Ref 2401242H

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805214171100A0197 Basic UDI-DIDate24 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030042-04 Issued

    Quality management system EU MDR

    Notified body
    ICIM S.P.A. 0425
    Issued
    20 Jun 2026
    Expires
    26 Sep 2028

Specification

EUDAMED

Device Name
Impianti Dentali Endossei / Dental endosseous implants
Model / Reference
2401242H
Primary DI / UDI-DI
08052141717325
Basic UDI-DI
805214171100A0197
EMDN Code
P01020101 Dental implants
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000022007

Other devices from Prodent Italia S.r.l.

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Properties

Show properties
  • Sterile
  • Implantable
  • Sutures
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