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Loupes

by Nanjing Yameng Intelligent Technology Co., Ltd China EUDAMED

Ref YJ2.5XModel YJ2.5X, YJ3.0X, YJ3.5X, YJ4.0X, JY5.0X, YJ6.0X, YJ8.0X, YJ4.5X, YJ5.5X, YJ6.5X, YJ8.5X, JC2.5X, JC3.0X, JC3.5X, JC4.0X, JC5.0X, JC6.0X, JC8.0X, TD2.5X, TD3.0X, TD3.5X, TD4.0X, TD5.0X, TD6.0X, TD8.0X

EMDN Y210699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697720455FDJRM Basic UDI-DIDate19 Apr 2024RegisteredStatusActive

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
Loupes
Model / Reference
YJ2.5X, YJ3.0X, YJ3.5X, YJ4.0X, JY5.0X, YJ6.0X, YJ8.0X, YJ4.5X, YJ5.5X, YJ6.5X, YJ8.5X, JC2.5X, JC3.0X, JC3.5X, JC4.0X, JC5.0X, JC6.0X, JC8.0X, TD2.5X, TD3.0X, TD3.5X, TD4.0X, TD5.0X, TD6.0X, TD8.0X
Primary DI / UDI-DI
06977204550003
Basic UDI-DI
697720455FDJRM
EMDN Code
Y210699 Electronic optical aids - other
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000039555
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Nanjing Yameng Intelligent Technology 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 8b89001e-45b4-4f4a-aa2a-c945afd92015 61 fields · synced 22 Oct 2026