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Digital Refractor

by POTEC Co., Ltd. South Korea EUDAMED

Ref Phoromat 2000Model PDR-7000, TAP-2000, Phoromat 2000

EMDN Z12120115

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88092400115ST Basic UDI-DIDate21 Apr 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Digital Refractor
Model / Reference
PDR-7000, TAP-2000, Phoromat 2000
Primary DI / UDI-DI
08809240018934
Basic UDI-DI
88092400115ST
Direct Marketing DI
08809240018934
EMDN Code
Z12120115 Optometers
Device Class
Class I
Market of Registration
Germany

Manufacturer details

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

Other devices from POTEC Co., Ltd.

See all devices from POTEC 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 253850f8-c4a6-4e45-b227-427db5194621 61 fields · synced 24 Oct 2026