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Solution Salina Balanceada Estéril

by Industria Farmaceutica Galenica Senese SRL 5 variants

Ref DD0412004Model Balanced Sterile Saline Solution solution for irrigation - Box containing 12 glass 500 mL bottles each

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08033959657782 Basic UDI-DI 08033959657782UDI-DIDate25 Sep 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  • Withdrawn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

Device Name
Balanced Sterile Saline Solution solution for irrigation
Model / Reference
Balanced Sterile Saline Solution solution for irrigation - Box containing 12 glass 500 mL bottles each, DD0412004
Primary DI / UDI-DI
08033959657782
Basic UDI-DI
B-08033959657782
EMDN Code
Q02030203 Ophthalmic surgery balanced saline solutions
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000028934

Other devices from Industria Farmaceutica Galenica Senese SRL

See all devices from Industria Farmaceutica Galenica Senese SRL →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • 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