Skip to content

AquaStar

by Instrumentation DIFRA 2 variants

Ref 17550Model AquaStar 115V

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-+B5160175500B Basic UDI-DI +B5160175500BUDI-DIDate1 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  • Withdrawn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
AquaStar 115V
Model / Reference
AquaStar 115V, 17550
Primary DI / UDI-DI
+B5160175500B
Basic UDI-DI
B-+B5160175500B
EMDN Code
Z12149004 Oto-caloric stimulators
Device Class
Class IIa
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000000867

Other devices from Instrumentation DIFRA

See all devices from Instrumentation DIFRA →

Properties

Other properties (11)

  • Sterile: No
  • 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