Skip to content

Rigidní fixace hlezna 065C, vel.2

by HANDICAP, a.s. EUDAMED

Active European Union

Ref 065C

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number859404276014JG Basic UDI-DIDate2 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Trade Name
Rigidní fixace hlezna 065C,vel.2
Rigidní fixace hlezna 065C,vel.1
Rigidní fixace hlezna 065C,vel.0
Rigidní fixace hlezna 065C,vel.3
Rigidní fixace hlezna 065C,vel.X0
Device Name
Rigidní fixace hlezna 065C
Model / Reference
065C
Primary DI / UDI-DI
08594042761941, 08594042761934, 08594042763426, 08594042761958, 08594042763914
Basic UDI-DI
859404276014JG
EMDN Code
Y06120601 Passive ankle-foot orthoses
Device Class
Class I
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000001007

Other devices from HANDICAP, a.s.

See all devices from HANDICAP, a.s. →

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