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Set Synicem KYP System

by Synergie Ingenierie Medicale France EUDAMED

Ref 880675Model Balloon 10mm

EMDN A019011

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-03700448213488 Basic UDI-DIDate17 Jul 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 24 Oct 2026

Device Name
Steril Balloon Kyphoplasty Set
Model / Reference
Balloon 10mm, 880675
Primary DI / UDI-DI
03700448213488
Basic UDI-DI
B-03700448213488
EMDN Code
A019011 Intraosseous infusion and vertebroplasty infusion needles and kits
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000001635

From the manufacturer

Manufacturer's product page: SYNICEM™ for kyphoplasty

Other devices from Synergie Ingenierie Medicale

See all devices from Synergie Ingenierie Medicale →

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 b975ac90-81b7-4d7e-98d7-654f38a75166 61 fields · synced 24 Oct 2026