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OPFix

by Rudolf Heintel Gesellschaft m.b.H. Austria EUDAMED

Ref HSOOPFIX1000P EMDN V0804

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number912004788-HSOOPFIX-N7 Basic UDI-DIDate2 Feb 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  • Withdrawn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 · synced 25 Oct 2026

Device Name
OPFix
Model / Reference
HSOOPFIX1000P
Primary DI / UDI-DI
09120047885079
Basic UDI-DI
912004788-HSOOPFIX-N7
EMDN Code
V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000050568

Other devices from Rudolf Heintel Gesellschaft m.b.H.

See all devices from Rudolf Heintel Gesellschaft m.b.H. →

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 cd4964cf-4e86-480d-9cbb-5bf2f74d3603 61 fields · synced 25 Oct 2026