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Smart Handle

by Indiba S.A.U. EUDAMED

Active European Union

Ref ACC1099MED/ACC1099

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8434251A13D8D9Z000FZ Basic UDI-DIDate7 Jan 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  • Withdrawn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

Device Name
Smart Handles
Model / Reference
ACC1099MED/ACC1099
Primary DI / UDI-DI
08434251004319
Basic UDI-DI
8434251A13D8D9Z000FZ
EMDN Code
X0599,Z12040203,Z120602
Device Class
Class IIb
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000001243

Other devices from Indiba S.A.U.

See all devices from Indiba S.A.U. →

Properties

Show properties
Other properties (13)
  • Sterile: No
  • 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