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Knee prosthesis- tibial insert

by Beijing LiDaKang Technology Co., Ltd. EUDAMED

Active European Union

Ref A5301-S109Model DD 01 / S1#-9mm

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06942494904980 Basic UDI-DIDate18 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Knee prosthesis- tibial insert
Model / Reference
DD 01 / S1#-9mm, A5301-S109
Primary DI / UDI-DI
06942494904980
Basic UDI-DI
B-06942494904980
EMDN Code
P090904020202 Unicompartmental knee prostheses tibial inserts, fixed
Device Class
Class III
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000027201
Authorised representative
Lotus NL B.V. NL-AR-000000121

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Properties

  • Sterile
  • Implantable

Other properties (11)

  • Reusable: 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