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1.56 Spherical Lenses

by Somo Inc.

Ref 08800138750646Model Plastic ophthalmic lenses

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88001387SOMO0001YP Basic UDI-DI 08800138750646UDI-DIDate22 May 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  • Withdrawn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

Model / Reference
Plastic ophthalmic lenses, 08800138750646
Primary DI / UDI-DI
08800138750646
Basic UDI-DI
88001387SOMO0001YP
Direct Marketing DI
08800138750646
EMDN Code
Q0210010101 Monofocal organic ophthalmic lenses
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
KR-MF-000035075
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Somo Inc.

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