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Phytosun Aroms

by Laboratoire de la Mer 4 variants

Ref OH1758100Model LABMER-004/A-01

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 Number356430LABMER-004/A-H6 Basic UDI-DI 03595890243585UDI-DIDate13 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  • Withdrawn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
Hypertonie seawater-based solution with aroma for nasal cavities cleansing, in Power Pouch continuous spray (PRD0915)
Model / Reference
LABMER-004/A-01, OH1758100
Primary DI / UDI-DI
03595890243585
Basic UDI-DI
356430LABMER-004/A-H6
Direct Marketing DI
03595890243585
EMDN Code
Q030103 Nasal irrigation solutions
Device Class
Class IIa
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000009050

Other devices from Laboratoire de la Mer

See all devices from Laboratoire de la Mer →

Properties

  • Animal Tissues

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No