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SEMA PROTECT Woda morska izotoniczna

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

Ref ENT02Model 100 ml, 30 ml, 50 ml, 100 ml, 150 ml

Active European Union

CE MDR 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/MDR NumberB-590376950186185 Basic UDI-DI Date10 Sep 2024RegisteredStatusActive
European UnionCE/MDD NumberB-590376950186185 Basic UDI-DI Date10 Sep 2024RegisteredStatusActive

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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Trade Name
SEMA PROTECT Woda morska izotoniczna
Sema Protect woda morska izotoniczna 100ml
Device Name
Woda morska izotoniczna
Model / Reference
100 ml, ENT02, 30 ml, 50 ml, 150 ml
Primary DI / UDI-DI
D-590376950186185, 05903769501861
Basic UDI-DI
B-590376950186185, 5906395089ENT02BL
EMDN Code
Q030103 Nasal irrigation solutions
Device Class
Class IIa
Class IIb
EU 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

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