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Espaciador de rodilla SUBITON

by Laboratorios SL S.A. EUDAMED

Active European Union

Ref 880915Model Simétrico y Asimétrico

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2024 DR 0035 Date9 Oct 2026IssuedStatusActive expires 18 Jul 2029

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2024 DR 0035 Active Amended

    Technical documentation EU MDR

    Notified body
    0318
    Issued
    9 Oct 2026
    Expires
    18 Jul 2029
    Reason
    Other

Specification

EUDAMED

Device Name
Espaciador de rodilla con gentamicina
Model / Reference
Simétrico y Asimétrico, 880915
Primary DI / UDI-DI
07798034469155
Basic UDI-DI
779803446Spacers-GZA
EMDN Code
P090908 Knee prostheses spacers
Device Class
Class III
Market of Registration
France

Manufacturer details

EUDAMED SRN
AR-MF-000023153
Authorised representative
Synergie Ingénierie Médicale FR-AR-000001802

Other devices from Laboratorios SL S.A.

See all devices from Laboratorios SL S.A. →

Properties

  • Sterile
  • Implantable
  • Incorporates Medicinal Product

Other properties (10)

  • 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