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OcuFlex

by Caregroup Sight Solution Private Limited 2 variants

Ref CAT-00000HP00-AModel ANU6

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08907745968041 Basic UDI-DI Date1 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
ANU6, CAT-00000HP00-A
Primary DI / UDI-DI
08907745968041, 08907745968034, 08907745968010
Basic UDI-DI
B-08907745968041, B-08907745968034, B-08907745968010
EMDN Code
P030102090102 IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC
Device Class
Class IIb
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
IN-MF-000024154
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Caregroup Sight Solution Private Limited

Properties

  • Sterile
  • Implantable

Other properties (9)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No