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P200, P200Dx

by Optos plc United Kingdom EUDAMED

Ref A1021Model P200, P200Dx

EMDN Z12120114

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-A1021KD Basic UDI-DIDate28 May 2025RegisteredStatusActive

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 22 Oct 2026

Device Name
Panoramic Ophthalmoscope 200
Model / Reference
P200, P200Dx, A1021
Primary DI / UDI-DI
D-A1021KD
Basic UDI-DI
B-A1021KD
EMDN Code
Z12120114 Ophthalmoscopes
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
GB-MF-000019460
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Optos plc

See all devices from Optos plc →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED cc7f2d5a-d007-4ac8-b4e2-82c566da9a4f 61 fields · synced 22 Oct 2026