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Spectacle Frames

by Wenzhou Higo Optical Co., Ltd 654 variants

Ref SF-M002Model CH7921,CH7930,SF-M002,SF-M001,SF-M003, HTM-2003,OB1023,RD26014,RD26060,HTM-2004, HTM2010,F5796LT,F5797LT,CH7917,OLD25074T,OLD25161T,OB1001 CH6804,25305,HTM-2015,HTM-2015,HTM-2017,PYT2700,PYT2712, PYT2715, from PYT2718 to PYT2725,PYT2727

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697473781RS3XB Basic UDI-DI 06974737810208UDI-DIDate9 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Spectacle Frames
Model / Reference
CH7921, CH7930, SF-M002, SF-M001, SF-M003, HTM-2003, OB1023, RD26014, RD26060, HTM-2004, HTM2010, F5796LT, F5797LT, CH7917, OLD25074T, OLD25161T, OB1001 CH6804, 25305, HTM-2015, HTM-2017, PYT2700, PYT2712, PYT2715, from PYT2718 to PYT2725, PYT2727
Primary DI / UDI-DI
06974737810208
Basic UDI-DI
697473781RS3XB
EMDN Code
Q02100201, Q02100202, Q02100203, Q02100299
Device Class
Class I
EU 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