Skip to content

Spectacle Frames

by Wenzhou Higo Optical Co., Ltd EUDAMED

Active European Union

Ref CH8803Model 2517,2508,LE8871,2513,2516,1159,2503,2509,ISA51004,CH8803,HF2402,CH6171,CH6181,CH6180 CH6160,HG7011,PYT2699-C1,PYT2704,PYT2705,PYT2706,PYT2707,PYT2708,PYT2709,PYT2711

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697473781SF19R4 Basic UDI-DIDate9 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Spectacle Frames
Model / Reference
2517, 2508, LE8871, 2513, 2516, 1159, 2503, 2509, ISA51004, CH8803, HF2402, CH6171, CH6181, CH6180 CH6160, HG7011,PYT2699-C1, PYT2704, PYT2705, PYT2706, PYT2707, PYT2708, PYT2709, PYT2711
Primary DI / UDI-DI
06974737810130
Basic UDI-DI
697473781SF19R4
EMDN Code
Q02100201,Q02100202,Q02100203,Q02100299
Device Class
Class I
Market of Registration
Latvia

Manufacturer details

EUDAMED SRN
CN-MF-000022737
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Wenzhou Higo Optical Co., Ltd

See all devices from Wenzhou Higo Optical Co., Ltd →

Properties

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