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EvoTears

by URSAPHARM Arzneimittel GmbH 9 variants

Ref 56.0068Model Lubricating eye drops

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4031626551134RA Basic UDI-DI 04031626001535UDI-DIDate26 Jun 2025RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Perfluorohexyloctane ophthalmic solution
Model / Reference
Lubricating eye drops, 56.0068
Primary DI / UDI-DI
04031626001535
Basic UDI-DI
4031626551134RA
EMDN Code
Q02030206 Eye lubricant solutions
Device Class
Class IIb
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
DE-MF-000007748

Other devices from URSAPHARM Arzneimittel GmbH

See all devices from URSAPHARM Arzneimittel GmbH →

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