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Renova Spine

by Biopsybell SRL Italy EUDAMED

Ref RES0812101J15L EMDN K010102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8033860FT18Y9 Basic UDI-DIDate22 Sep 2026RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Device Name
Kyphoplasty Kit
Model / Reference
RES0812101J15L
Primary DI / UDI-DI
08033860032388
Basic UDI-DI
8033860FT18Y9
EMDN Code
K010102 Minimally invasive surgery kits, single-use
Device Class
Class IIa
Medical Purpose
KYPHOPLASTY

Manufacturer details

EUDAMED SRN
IT-PR-000012559

Other devices from Biopsybell SRL

See all devices from Biopsybell SRL →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED 08033860032388|8033860FT18Y9 61 fields · synced 24 Oct 2026