Skip to content

CEMEX GENTA SYSTEM 80g

by Tecres S.p.A.

Ref 1500/SG

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 Number80314970161NP Basic UDI-DI 28031497000224UDI-DIDate4 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 738112 Active Amended

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    19 Feb 2026
    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  • Withdrawn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
Cemex Genta System
Model / Reference
1500/SG
Primary DI / UDI-DI
28031497000224
Basic UDI-DI
80314970161NP
EMDN Code
P099002 Orthopaedic cement preparation and application devices and kits
Device Class
Class III
EU market of registration
Spain

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
  • CMR Substance
  • Animal Tissues
  • Incorporates Medicinal Product

Other properties (8)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No