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Trial Frame

by Hasegawa Bicoh co., ltd. Japan EUDAMED

Ref MC486 FULL RIMModel MC486 FULL RIM, MC674 FULL RIM, 580Univ Pro FULL RIM

EMDN Z12129099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number457120967TrialFrameXT Basic UDI-DIDate9 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Trial Frame
Model / Reference
MC486 FULL RIM, MC674 FULL RIM, 580Univ Pro FULL RIM
Primary DI / UDI-DI
04571209675703
Basic UDI-DI
457120967TrialFrameXT
EMDN Code
Z12129099 Various ophtalmology instruments - other
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
JP-MF-000029853
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hasegawa Bicoh 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 99f86b29-75ab-4cc1-be44-d8b477097d89 61 fields · synced 22 Oct 2026