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Ty&Já® lubrikační gel silikonový

by Dr. Müller Pharma s.r.o.

Ref PC0253_001

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2023-MDR/QS-031 Date15 Oct 2024IssuedStatusActive expires 20 Oct 2028

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2023-MDR/QS-031 Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    20 Oct 2023
    Expires
    20 Oct 2028
  • 2023-MDR/QS-031 Active Reissued

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    15 Oct 2024
    Expires
    20 Oct 2028

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Lubrikační gel silikonový
Model / Reference
PC0253_001
Primary DI / UDI-DI
08595610405991
Basic UDI-DI
85956104LGS5W
EMDN Code
M9002 Protective devices, lubricants and soothing devices (sprays, gels, fluids and creams)
Device Class
Class IIb
EU market of registration
Czechia

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