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Optava Fusion

by Allergan Sales, LLC 2 variants

Ref 94607EK

Expiring European Union

CE MDR

Valid until

6 May 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DEKRA Certification B.V.

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 Number0840228300034F Basic UDI-DI 10840228301247UDI-DIDate4 Aug 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3829879CE01 Expiring Expires in 182 days

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    6 May 2022
    Expires
    6 May 2027

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
Dry Eye Comfort Solutions and Ointments
Model / Reference
94607EK
Primary DI / UDI-DI
10840228301247
Basic UDI-DI
0840228300034F
Direct Marketing DI
10840228301247
EMDN Code
Q02030206, Q02030299, Q0299
Device Class
Class IIb
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000001517
Authorised representative
Allergan Pharmaceuticals International Limited IE-AR-000000650

Other devices from Allergan Sales, LLC

See all devices from Allergan Sales, LLC →

Properties

  • Sterile
  • CMR Substance
  • Administering Medicine

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No