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Auto Lensmeter

by POTEC Co., Ltd. South Korea EUDAMED

Ref PLM-8000Model PLM-8000PD

EMDN Z12129099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88092400112SM Basic UDI-DIDate8 Aug 2023RegisteredStatusActive

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
Auto Lensmeter
Model / Reference
PLM-8000PD, PLM-8000
Primary DI / UDI-DI
08809240018811
Basic UDI-DI
88092400112SM
Direct Marketing DI
08809240018811
EMDN Code
Z12129099 Various ophtalmology instruments - other
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000012281
Authorised representative
MDSS GmbH DE-AR-000005430

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 32730dfb-dfc9-4c0b-9db9-91d0645fde34 61 fields · synced 22 Oct 2026