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Presto® WOUND AND EYE RINSE SPRAY, 50 ml

by Aurena Laboratories AB

Ref 301531Model REF 2002

Expiring European Union

CE MDR

Valid until

27 Oct 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number28620131862-04 Date10 Jun 2026IssuedStatusExpiring expires 27 Oct 2027

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 28620131862-04 Expiring Supplemented Expires in 361 days

    Quality management system EU MDR

    Certifier
    Intertek Medical Notified Body AB 2862
    Issued
    10 Jun 2026
    Expires
    27 Oct 2027
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
Wound and Eye Wash Spray
Model / Reference
REF 2002, 301531
Primary DI / UDI-DI
07332343301524
Basic UDI-DI
7332343200017D
Direct Marketing DI
07332343301524
EMDN Code
M04040101 Saline dressings, non-combined
Device Class
Class IIa
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000002890

Other devices from Aurena Laboratories AB

See all devices from Aurena Laboratories AB →

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