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Auto Phoropter

by Taiyuan North China Xinyuan Tech Center (Co., Ltd) China EUDAMED

Ref FA-8000KP

EMDN Z1212012001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697546734200NK Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
FA-8000KP
Primary DI / UDI-DI
06975467342038
Basic UDI-DI
697546734200NK
Direct Marketing DI
06975467342038
EMDN Code
Z1212012001 Visual functional assessment equipment
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000031606
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Taiyuan North China Xinyuan Tech Center (Co., Ltd)

See all devices from Taiyuan North China Xinyuan Tech Center (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 ade9e251-14c5-4bb7-b9dc-892e4cb12b5b 61 fields · synced 23 Oct 2026