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Screw for Ucla and Abutment 3.3 He (Hexagonal)

by Systhex Sistemas De Implantes Ósseo Integrado Ltda EUDAMED

Active European Union

Ref 864001

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-*+D99486400109* Basic UDI-DIDate6 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Titanium Components
Model / Reference
864001
Primary DI / UDI-DI
*+D99486400109*
Basic UDI-DI
B-*+D99486400109*
EMDN Code
P01020180 Dental implants - accessories
Device Class
Class IIb
Market of Registration
Portugal

Manufacturer details

EUDAMED SRN
BR-MF-000043219
Authorised representative
SBP PORTUGAL LDA PT-AR-000042998

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Properties

  • 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