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Optical Frame

by Chongqing Huateng Import and Export Trading Co., Ltd China EUDAMED

Ref R10V26 C2, MEDINA L3, R10V12 C2, FIDI L4, R10V07 C2, OLINDA LIV L2, R10V01 C3, AIDA L2, R10V15 C1, R10V31 C1, ISBRE L1, KUMI L2, R10V04 C2, R10V02 C3, R10V12 C3, R10V30 C3, R10V23 C2, R10V19 C3, SOPHIE L1, R10V30 C2, R10V28 C3, R10V28 C1, R10V03 C3, ANTRANITA II L3, R10V05 C2, R10V06 C2, R10V14 C3, R10V03 C1, VISAGE L1, R10V32 C3, R10V13 C1, MIRA L4, ISBRE L2, TIGRA L3, CLINT L4, VISAGE L2, R10V07 C3, MEDINA L4, FEMI L3, R10V30 C5, Saubi L5, R10V32 C2, OLINDA LVII L3, Saubi L3, R10V30 C1, MIRA L3, AIDA L5, R10V13 C2, FLORIDA L1, R10V18 C2, SOPHIE L4Model LEONI FEMI Saubi TERI SOPHIE AIDA TORA MORGAN CLINT

EMDN Q02100202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697806075OF001H5 Basic UDI-DIDate10 Jan 2025RegisteredStatusActive

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
Optical Frame
Model / Reference
LEONI FEMI Saubi TERI SOPHIE AIDA TORA MORGAN CLINT, R10V26 C2, MEDINA L3, R10V12 C2, FIDI L4, R10V07 C2, OLINDA LIV L2, R10V01 C3, AIDA L2, R10V15 C1, R10V31 C1, ISBRE L1, KUMI L2, R10V04 C2, R10V02 C3, R10V12 C3, R10V30 C3, R10V23 C2, R10V19 C3, SOPHIE L1, R10V30 C2, R10V28 C3, R10V28 C1, R10V03 C3, ANTRANITA II L3, R10V05 C2, R10V06 C2, R10V14 C3, R10V03 C1, VISAGE L1, R10V32 C3, R10V13 C1, MIRA L4, ISBRE L2, TIGRA L3, CLINT L4, VISAGE L2, R10V07 C3, MEDINA L4, FEMI L3, R10V30 C5, Saubi L5, R10V32 C2, OLINDA LVII L3, Saubi L3, R10V30 C1, MIRA L3, AIDA L5, R10V13 C2, FLORIDA L1, R10V18 C2, SOPHIE L4
Primary DI / UDI-DI
06978060753348, 06978060750323, 06978060753058, 06978060751542, 06978060752907, 06978060751825, 06978060752730, 06978060750880, 06978060753133, 06978060753478, 06978060751610, 06978060752129, 06978060752815, 06978060752761, 06978060753065, 06978060753447, 06978060753287, 06978060753256, 06978060750040, 06978060753430, 06978060753386, 06978060753362, 06978060752792, 06978060752334, 06978060752846, 06978060752877, 06978060753126, 06978060752778, 06978060750200, 06978060753539, 06978060753072, 06978060752648, 06978060751627, 06978060750521, 06978060751443, 06978060750217, 06978060752914, 06978060750330, 06978060750804, 06978060753461, 06978060751009, 06978060753522, 06978060751931, 06978060750989, 06978060753423, 06978060752631, 06978060750910, 06978060753089, 06978060750408, 06978060753218, 06978060751177
Basic UDI-DI
697806075OF001H5
EMDN Code
Q02100202, Q02100201
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000044775
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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See all devices from Chongqing Huateng Import and Export Trading 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 (51)

  • EUDAMED c7dc3c91-7bd9-47d4-8d6e-9e21ee34aead 61 fields · synced 22 Oct 2026
  • EUDAMED 06978060750323|697806075OF001H5 61 fields · synced 11 May 2026
  • EUDAMED 06978060753058|697806075OF001H5 61 fields · synced 11 May 2026
  • EUDAMED 06978060751542|697806075OF001H5 61 fields · synced 16 May 2026
  • EUDAMED 06978060752907|697806075OF001H5 61 fields · synced 16 May 2026
  • EUDAMED 06978060751825|697806075OF001H5 61 fields · synced 16 May 2026
  • EUDAMED 06978060752730|697806075OF001H5 61 fields · synced 16 May 2026
  • EUDAMED 06978060750880|697806075OF001H5 61 fields · synced 16 May 2026
  • EUDAMED 06978060753133|697806075OF001H5 61 fields · synced 16 May 2026
  • EUDAMED 06978060753478|697806075OF001H5 61 fields · synced 16 May 2026
  • EUDAMED 06978060751610|697806075OF001H5 61 fields · synced 16 May 2026
  • EUDAMED 06978060752129|697806075OF001H5 61 fields · synced 16 May 2026
  • EUDAMED 06978060752815|697806075OF001H5 61 fields · synced 16 May 2026
  • EUDAMED 06978060752761|697806075OF001H5 61 fields · synced 16 May 2026
  • EUDAMED 06978060753065|697806075OF001H5 61 fields · synced 16 May 2026
  • EUDAMED 06978060753447|697806075OF001H5 61 fields · synced 16 May 2026
  • EUDAMED 06978060753287|697806075OF001H5 61 fields · synced 16 May 2026
  • EUDAMED 06978060753256|697806075OF001H5 61 fields · synced 16 May 2026
  • EUDAMED 06978060750040|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060753430|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060753386|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060753362|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060752792|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060752334|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060752846|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060752877|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060753126|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060752778|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060750200|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060753539|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060753072|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060752648|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060751627|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060750521|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060751443|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060750217|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060752914|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060750330|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060750804|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060753461|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060751009|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060753522|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060751931|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060750989|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060753423|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060752631|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060750910|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060753089|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060750408|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060753218|697806075OF001H5 61 fields · synced 17 May 2026
  • EUDAMED 06978060751177|697806075OF001H5 61 fields · synced 17 May 2026