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fytofontana HEMORRELAX suppositories

by Herb-Pharma Corporation s.r.o. Slovakia EUDAMED

Ref 14008 EMDN V9099

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2026-MDR/QS-009/A Date16 Jul 2026IssuedStatusActive expires 18 Apr 2029

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  • Withdrawn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)
  • 2026-MDR/QS-009/A Supplemented

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    16 Jul 2026
    Expires
    18 Apr 2029
    Reason
    Other

Specification

EUDAMED · synced 22 Oct 2026

Device Name
fytofontana HEMORRELAX rectal suppositories
Model / Reference
14008
Primary DI / UDI-DI
18588009456633
Basic UDI-DI
858800945614008VD
EMDN Code
V9099 Various devices not included in other classes - other
Device Class
Class IIb
Market of Registration
Slovakia

Manufacturer details

EUDAMED SRN
SK-MF-000005839

Other devices from Herb-Pharma Corporation s.r.o.

See all devices from Herb-Pharma Corporation s.r.o. →

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 773bc0d7-1691-48ba-bcd9-b3c1799ea6a7 61 fields · synced 22 Oct 2026