Skip to content

Elysium Steril Hipertóniás Sóoldat 3% 20 x 5 mL

by Unolab manufacturing, S.L.

Ref PSU-0006Model Saline Solution 3%

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-8437009065010010038K Basic UDI-DI D-8437009065010010038KUDI-DIDate24 Aug 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  • Withdrawn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

Model / Reference
Saline Solution 3%, PSU-0006
Primary DI / UDI-DI
D-8437009065010010038K
Basic UDI-DI
B-8437009065010010038K
EMDN Code
Q030199 Nasopharyngeal devices - other
Device Class
Class IIa
EU market of registration
Hungary

Manufacturer details

EUDAMED SRN
ES-MF-000000272

Other devices from Unolab manufacturing, S.L.

See all devices from Unolab manufacturing, S.L. →

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