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Spacer-S 46

by Tecres S.p.A.

Ref SPS46/G

Active European Union

CE MDR

Valid until

16 Jan 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number80314970231NK Basic UDI-DI 28031497000378UDI-DIDate7 Jul 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 739361 Active Amended

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    10 Dec 2025
    Expires
    16 Jan 2028
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Spacer-S
Model / Reference
SPS46/G
Primary DI / UDI-DI
28031497000378
Basic UDI-DI
80314970231NK
EMDN Code
P090199 Shoulder prostheses - other
Device Class
Class III
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000027512

Other devices from Tecres S.p.A.

See all devices from Tecres S.p.A. →

Properties

  • Sterile
  • Implantable
  • Animal Tissues
  • Incorporates Medicinal Product

Other properties (9)

  • 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