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Osmotears Ultra Low OS 180 (OS180-001)

by Enable Innovations SRL

Ref 050204Model Goccia oculare Osmotears Ultra Low 180

Active European Union

CE MDR

Valid until

2 Feb 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier ICIM S.P.A.

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/MDR Number80540851219P4 Basic UDI-DI 08054085120636UDI-DIDate15 Apr 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030119-01 Active Supplemented

    Quality management system EU MDR

    Certifier
    ICIM S.P.A. 0425
    Issued
    25 Feb 2026
    Expires
    2 Feb 2030
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Goccia oculare Osmotears Ultra Low 180
Model / Reference
Goccia oculare Osmotears Ultra Low 180, 050204
Primary DI / UDI-DI
08054085120636
Basic UDI-DI
80540851219P4
EMDN Code
Q0299 Ophthalmic devices - other
Device Class
Class IIb
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
IT-MF-000026066

Other devices from Enable Innovations SRL

See all devices from Enable Innovations SRL →

Properties

  • Sterile

Other properties (12)

  • 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