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Siringa Gel Lubrificante

by Betatex SpA Italy EUDAMED

Ref MTK0026 EMDN A02010799

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805330078SBSH9 Basic UDI-DIDate10 Apr 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Siringhe / Bustine / Soffietti prerimpiti di Gel Lubrificante per Cateterismo Vescicale
Model / Reference
MTK0026
Primary DI / UDI-DI
08053807810329
Basic UDI-DI
805330078SBSH9
EMDN Code
A02010799 Prefilled syringes - other
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000009955

Other devices from Betatex SpA

See all devices from Betatex SpA →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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

Sources (1)

  • EUDAMED 312db42a-50db-46d0-9a06-9c3f3b66f538 61 fields · synced 22 Oct 2026