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Custom Pack Cataratta

by Betatex SpA Italy EUDAMED

Ref SB0039SE

EMDN T0202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-SB0039SE58 Basic UDI-DIDate2 Feb 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
SB0039SE
Primary DI / UDI-DI
D-SB0039SE58
Basic UDI-DI
B-SB0039SE58
EMDN Code
T0202 Surgical procedural kits (excluding surgical instrument kits)
Device Class
Class IIa
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 (10)
  • 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

Sources (1)

  • EUDAMED c5f14283-3015-492a-b426-faa5ad5992a7 61 fields · synced 24 Oct 2026