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SmartMix™ Syringe Gun

by Summit Medical Ltd United Kingdom EUDAMED

Ref 5401-76-513 EMDN P099002

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50602382010A5F Basic UDI-DIDate10 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Bone Cement Delivery Gun
Model / Reference
5401-76-513
Primary DI / UDI-DI
05060238201377
Basic UDI-DI
50602382010A5F
Direct Marketing DI
05060238201377
EMDN Code
P099002 Orthopaedic cement preparation and application devices and kits
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000019193
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Summit Medical Ltd

See all devices from Summit Medical Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (12)
  • Sterile: No
  • Implantable: 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

Sources (1)

  • EUDAMED 69885f2b-c7b2-4946-a708-8fb629a1ebe2 61 fields · synced 25 Oct 2026