Skip to content

HYALOSAN vaginal gel with hyaluronic acid

by Dr. Müller Pharma s.r.o.

Ref PC0251_004

Active European Union

CE MDR

Valid until

20 Oct 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2023-MDR/QS-033/B Date2 May 2025IssuedStatusActive EUDAMED: not on the EU market expires 20 Oct 2028

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2023-MDR/QS-032 Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    20 Oct 2023
    Expires
    20 Oct 2028
  • 2023-MDR/QS-033/B Active Supplemented

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    2 May 2025
    Expires
    20 Oct 2028
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Vaginální gel s kyselinou hyaluronovou
Model / Reference
PC0251_004
Primary DI / UDI-DI
08595610406806
Basic UDI-DI
85956104VGHAYC
EMDN Code
U0803 Vaginal devices in the form of solutions/creams/ova/tablets
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
CZ-MF-000000005

Other devices from Dr. Müller Pharma s.r.o.

See all devices from Dr. Müller Pharma 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