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Plastic Optical Frame with Clip on

by Wenzhou Higo Optical Co., Ltd EUDAMED

Active European Union

Ref C1128C4Model 9243,9104,969,997,C2403,971,914,1001,PYT2701-C1

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697473781SF118NK 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  • Withdrawn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
Plastic Optical Frame with Clip on
Model / Reference
9243, 9104, 969, 997, C2403, 971, 914, 1001, PYT2701-C1, C1128C4
Primary DI / UDI-DI
06974737819218
Basic UDI-DI
697473781SF118NK
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