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hydropastilky

by GENERICA, spol. s r.o. Slovakia EUDAMED

Ref 8588003769992 EMDN Q0399

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8588003769hp20N2 Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2024-MDR/QS-065 Issued

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    28 Nov 2024
    Expires
    28 Nov 2029

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Pastilky
Model / Reference
8588003769992
Primary DI / UDI-DI
08588003769992
Basic UDI-DI
8588003769hp20N2
Direct Marketing DI
08588003769992
EMDN Code
Q0399 ENT devices - other
Device Class
Class IIa
Market of Registration
Slovakia

Manufacturer details

EUDAMED SRN
SK-MF-000036382

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 29a2bef9-05b7-48d4-8363-43a4e2d2bbfa 61 fields · synced 24 Oct 2026