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Balloon Kyphoplasty Kits

by Beijing Bonsci Technology Co., Ltd. China EUDAMED

Ref A500326Model K03A EMDN P091399

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06974754671240 Basic UDI-DIDate11 Apr 2024RegisteredStatusActive

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  • Withdrawn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 · synced 24 Oct 2026

Device Name
Balloon Kyphoplasty Kits
Model / Reference
K03A, A500326
Primary DI / UDI-DI
06974754671240
Basic UDI-DI
B-06974754671240
EMDN Code
P091399 Orthopaedic implant instruments, single-use - other
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000013535
Authorised representative
Lotus NL B.V. NL-AR-000000121

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Category: Joint prosthesis implantation kit, single-use

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • 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 0cb60625-b74e-4973-b9be-de0a8070f213 61 fields · synced 24 Oct 2026