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Woda morska hipertoniczna (APTEO)

by Gofarm Sp. z o.o. Sp. k. EUDAMED

Active European Union

Ref ENT09Model 100 ml, 30 ml, 50 ml, 100 ml, 150 ml

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-59037695017798K Basic UDI-DIDate18 Mar 2025RegisteredStatusActive
European UnionCE/MDD NumberB-59037695017798K Basic UDI-DIDate18 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Woda morska hipertoniczna
Model / Reference
100 ml, ENT09, 30 ml, 50 ml, 150 ml
Primary DI / UDI-DI
D-59037695017798K, 05903769501779
Basic UDI-DI
B-59037695017798K, 5906395089ENT09C2
EMDN Code
Q030103 Nasal irrigation solutions
Device Class
Class IIa
Class IIb
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000003485

Other devices from Gofarm Sp. z o.o. Sp. k.

See all devices from Gofarm Sp. z o.o. Sp. k. →

Properties

Show 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