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Specular Microscope SPM-700

by Rexxam Co., Ltd. Kagawa Factory Japan EUDAMED

Ref SP003Model SPM-700

EMDN Z12120110

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04540008319965 Basic UDI-DIDate14 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
SPM-700, SP003
Primary DI / UDI-DI
04540008319965
Basic UDI-DI
B-04540008319965
EMDN Code
Z12120110 Corneal confocal microscopes
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
JP-MF-000004361
Authorised representative
REXXAM CZECH s.r.o. CZ-AR-000025243

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Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 8f8e6357-42b6-4f6f-9a23-cc1994d104e6 61 fields · synced 24 Oct 2026