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OtriBaby

by Haleon CH SARL

Ref A1K0000000X4008

Active European Union

CE MDR

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/MDR Number50596230DP00000000V001CG Basic UDI-DI 05054563165350UDI-DIDate19 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Otrivin Sea Water with/without Aloe Vera Nasal Spray
Model / Reference
A1K0000000X4008
Primary DI / UDI-DI
05054563165350
Basic UDI-DI
50596230DP00000000V001CG
EMDN Code
Q030103 Nasal irrigation solutions
Device Class
Class IIa
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
CH-MF-000017560
Authorised representative
Haleon Medical Devices IE-AR-000003845

Other devices from Haleon CH SARL

See all devices from Haleon CH SARL →

Properties

Other properties (13)

  • Sterile: No
  • 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