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Zápěstní ortéza 045B levá, vel.4, černá

by HANDICAP, a.s. EUDAMED

Active European Union

Ref 045B

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number859404276012JC Basic UDI-DIDate31 Aug 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  • Withdrawn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
Zápěstní ortéza 045B levá,vel.4,černá
Zápěstní ortéza 045B levá,vel.2,černá
Zápěstní ortéza 045B levá,vel.1,černá
Zápěstní ortéza 045B levá,vel.3,černá
Zápěstní ortéza 045B levá,vel.0,černá
Device Name
Ortéza zápěstí 045B
Model / Reference
045B
Primary DI / UDI-DI
08594042762481, 08594042762306, 08594042762290, 08594042762313, 08594042762283
Basic UDI-DI
859404276012JC
EMDN Code
Y060609 Wrist (forearm) 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