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A3 GT PS Tibial Insert

by Beijing AK Medical Co., Ltd. China EUDAMED

Ref A1328-2016Model DE#16mm

EMDN P090903020202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06943735135941 Basic UDI-DIDate15 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
DE#16mm, A1328-2016
Primary DI / UDI-DI
06943735135941
Basic UDI-DI
B-06943735135941
EMDN Code
P090903020202 Bicompartmental primary implant fixed bearing tibial inserts
Device Class
Class III

Manufacturer details

EUDAMED SRN
CN-MF-000018814
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED cef33943-cc2e-4019-bb4c-d8918d49c70d 61 fields · synced 22 Oct 2026