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Unisept Otic Drops

by Ioulia and Irene Tseti Pharmaceutical Laboratories S.A.

Ref UNISEPT OTIC DROPSModel UNISEPT OTIC DROPS 30mL, UNISEPT OTIC DROPS 10mL

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-UNSPTMD6704309V Basic UDI-DI Date21 Sep 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
UNISEPT OTIC DROPS 30mL, UNISEPT OTIC DROPS, UNISEPT OTIC DROPS 10mL
Primary DI / UDI-DI
D-UNSPTMD6704309V, D-UNSPTMD6704JR
Basic UDI-DI
B-UNSPTMD6704309V, B-UNSPTMD6704JR
EMDN Code
Q03040299 Ear irrigation devices - other
Device Class
Class I
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
GR-MF-000032958

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Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No