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fytofontana GYNTIMA Probiotica vaginal suppositories

by Herb-Pharma Corporation s.r.o.

Ref 02023

Active European Union

CE MDR

Valid until

18 Apr 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2025-MDR/QS-003/A Date9 Jan 2026IssuedStatusActive expires 18 Apr 2029

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2025-MDR/QS-003/A Active Supplemented

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    9 Jan 2026
    Expires
    18 Apr 2029
    Reason
    Other

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
fytofontana GYNTIMA suppositories
fytofontana GYNTIMA vaginal suppositories
Model / Reference
02023
Primary DI / UDI-DI
18588009456404, 08588009456407
Basic UDI-DI
858800945602023242526A9
Direct Marketing DI
18588009456404
EMDN Code
U0803 Vaginal devices in the form of solutions/creams/ova/tablets
Device Class
Class IIb
EU 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

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