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Head Immobilizer

by Anping Guardian Medical Equipment Co., Ltd China EUDAMED

Ref HI-RModel AZ-HI01、AZ-HI-01、AZ-HI-02、AZ-HI-03、AZ-HI-05、AZ-HIA、AZ-HIA-01、AZ-HIA-02、AZ-HIA-03、AZ-HIA-04、AZ-HIS

EMDN Y060699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697310523AZHIHG Basic UDI-DIDate9 Dec 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
AZ-HI01、AZ-HI-01、AZ-HI-02、AZ-HI-03、AZ-HI-05、AZ-HIA、AZ-HIA-01、AZ-HIA-02、AZ-HIA-03、AZ-HIA-04、AZ-HIS, HI-R
Primary DI / UDI-DI
06973105230594
Basic UDI-DI
697310523AZHIHG
EMDN Code
Y060699 Orthoses, upper extremity - other
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000015025
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Anping Guardian Medical Equipment Co., Ltd

See all devices from Anping Guardian Medical Equipment Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 06973105230594|697310523AZHIHG 61 fields · synced 25 Oct 2026