Skip to content

Optical Frames

by Wenzhou Robo Import & Export Co., Ltd EUDAMED

Active European Union

Ref RTA-5105Model PLASITC OPTICAL FRAMES:RTA-5201,RTA-5202,RTA-5203,RTA-5204,RTA-5205,RTA-5206,RTA-5207,RTA-5101,RTA-5102,RTA-5103,RTA-5104,RTA-5105,RTA-5106,RTA-5107,RTA-5108,RTA-4901,RTA-4902,RTA-4903,RTA-4904,RTA-4905,RTA-4906,RTA-4811,RTA-4812,RTA-4813,RTA-4814, etc

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6975196842200102VX Basic UDI-DIDate18 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
Optical Frames
Model / Reference
PLASITC OPTICAL FRAMES:RTA-5201, RTA-5202, RTA-5203, RTA-5204, RTA-5205, RTA-5206, RTA-5207, RTA-5101, RTA-5102, RTA-5103, RTA-5104, RTA-5105, RTA-5106, RTA-5107, RTA-5108, RTA-4901, RTA-4902, RTA-4903, RTA-4904, RTA-4905, RTA-4906, RTA-4811, RTA-4812, RTA-4813, RTA-4814, etc
Primary DI / UDI-DI
06975196840119
Basic UDI-DI
6975196842200102VX
EMDN Code
Q02100202 Plastic spectacle frames without lenses
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000015287
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Wenzhou Robo Import & Export Co., Ltd

See all devices from Wenzhou Robo Import & Export 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