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LINK Spacer Shoulder

by Laboratorios SL S.A. 2 variants

Ref 884441Model HA40 - HA48

LINK Spacer Shoulder (884441) is a Class III device made by Laboratorios SL S.A., registered in EUDAMED on 19 Mar 2026 (Basic UDI-DI 779803446SpacerShoulderFM) with CE/MDR certificate 2026 DR 0072 valid until 18 Jul 2029, active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

18 Jul 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2026 DR 0072 Date9 Oct 2026IssuedStatusActive expires 18 Jul 2029

Official records

  • EUDAMED public site Basic UDI-DI 779803446SpacerShoulderFM — open Devices and search for it

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2026 DR 0072 Active Amended

    Technical documentation EU MDR

    Certifier
    CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS 0318
    Issued
    9 Oct 2026
    Expires
    18 Jul 2029
    Reason
    Other

Timeline

3 dated events

  1. Registered EUDAMED 779803446SpacerShoulderFM
  2. Certificate issued EUDAMED 2026 DR 0072
  3. Certificate expires EUDAMED 2026 DR 0072

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Espaciador de Hombro con Gentamicina
Model / reference
HA40 - HA48, 884441
Primary DI / UDI-DI
07798034468103
Basic UDI-DI
779803446SpacerShoulderFM
EMDN code
P090199 Shoulder prostheses - other
Device class
Class III
EU registration type
Standard device
EU market of registration
France

Manufacturer details

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

Similar devices in this category

Other devices filed under SHOULDER PROSTHESES - OTHER.

Other devices from Laboratorios SL S.A.

See all devices from Laboratorios SL S.A. →

Properties

  • Supplied sterile
  • Implantable
  • Incorporates a medicinal substance
Other properties (11, all answered No)