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Abfen Sinus Rinse Kit Hipertonic Pediatric

by Abfen Farma İlaç San. Ve Ti̇c. A.Ş.

Ref Abfen Sinus Rinse Kit Hipertonic PediatricModel (Naso/Abfen Sinus) Rinse Kit Hipertonic Pediatric

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08699220000192 Basic UDI-DI 08699220000192UDI-DIDate21 May 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  • Withdrawn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
(Naso/Abfen Sinus) Rinse Kit Hipertonic Pediatric
Model / Reference
(Naso/Abfen Sinus) Rinse Kit Hipertonic Pediatric, Abfen Sinus Rinse Kit Hipertonic Pediatric
Primary DI / UDI-DI
08699220000192
Basic UDI-DI
B-08699220000192
EMDN Code
Q030103 Nasal irrigation solutions
Device Class
Class IIa
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000042203

Other devices from Abfen Farma İlaç San. Ve Ti̇c. A.Ş.

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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