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Camera, still, surgical

by PSI Plus Co., Ltd. South Korea EUDAMED

Ref Meta001, Mark001, Mark002Model 3D Meta-Vu, Mark-Vu, Mark-Vu W

EMDN Z12040108

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08809978120017Q Basic UDI-DIDate20 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
3D Meta-Vu, Meta001, Mark-Vu, Mark001, Mark-Vu W, Mark002
Primary DI / UDI-DI
08809978120015, 08809978120008, 08809978120022
Basic UDI-DI
08809978120017Q, 08809978120007N, 08809978120022YH
EMDN Code
Z12040108 Dermatoscopes
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
KR-MF-000047814
Authorised representative
SMGeurope OÜ EE-AR-000048466

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 (3)

  • EUDAMED 3d8d1374-c441-4541-81f5-764450af8630 61 fields · synced 22 Oct 2026
  • EUDAMED 08809978120008|08809978120007N 61 fields · synced 16 May 2026
  • EUDAMED 08809978120022|08809978120022YH 61 fields · synced 18 May 2026