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K-Inject

by Biopsybell SRL Italy EUDAMED

Ref KK-GUNP

EMDN P099002

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8033860KYPFT05A1S3Z Basic UDI-DIDate20 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • IT353495 Amended

    Quality management system EU MDR

    Notified body
    BUREAU VERITAS ITALIA S.P.A. 1370
    Issued
    4 Sep 2026
    Expires
    14 Jun 2031
    Reason
    Other
  • IT349638 Withdrawn

    Quality assurance EU MDR

    Notified body
    BUREAU VERITAS ITALIA S.P.A. 1370
    Issued
    10 Feb 2026
    Expires
    9 Feb 2030
    Reason
    Other

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Accessories for Bone Augmentation Material Injection
Model / Reference
KK-GUNP
Primary DI / UDI-DI
08033860052164
Basic UDI-DI
8033860KYPFT05A1S3Z
EMDN Code
P099002 Orthopaedic cement preparation and application devices and kits
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000011601

Other devices from Biopsybell SRL

See all devices from Biopsybell SRL →

Properties & raw data

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

Sources (1)

  • EUDAMED 08033860052164|8033860KYPFT05A1S3Z 61 fields · synced 24 Oct 2026