Skip to content

Auridol

by Emergopharm Spółka z ograniczoną odpowiedzialnością 5 variants

Active European Union

CE MDR

Valid until

18 May 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

3 certificates

Certifier TUV NORD Polska Sp. z o.o

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberTNP/MDR/0054/5756/2026 Date26 Aug 2026IssuedStatusActive EUDAMED: not on the EU market expires 18 May 2031

Certificates

3 certificates · EUDAMED

EUDAMED certificates (3)
  • TNP/MDR/0054/5756/2026 Active Supplemented Removed from EUDAMED

    Quality management system EU MDR

    Issued
    5 Aug 2026
    Expires
    18 May 2031
    Reason
    Add device or group
  • TNP/MDR/0054/5756/2026 Active Supplemented

    Quality management system EU MDR

    Issued
    26 Aug 2026
    Expires
    18 May 2031
    Reason
    Add device or group
  • TNP/MDR/0060/5756/2026 Active

    Technical documentation EU MDR

    Issued
    6 Aug 2026
    Expires
    18 May 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Primary DI / UDI-DI
05905718013227
Basic UDI-DI
5902020885058X
Direct Marketing DI
05905718013227
EMDN Code
M9002 Protective devices, lubricants and soothing devices (sprays, gels, fluids and creams)
Device Class
Class III

Manufacturer details

EUDAMED SRN
PL-MF-000007178

Other devices from Emergopharm Spółka z ograniczoną odpowiedzialnością

See all devices from Emergopharm Spółka z ograniczoną odpowiedzialnością →

Properties

  • Incorporates Medicinal Product

Other properties (12)

  • 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