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Picc Line Dressing Kit

by Betatex SpA Italy EUDAMED

Ref MTK1058/ISK-19 EMDN T0202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805330078CVCFM Basic UDI-DIDate8 Feb 2024RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CSQ0001220523 Supplemented

    Quality management system EU MDR

    Notified body
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    2 Nov 2023
    Expires
    23 Oct 2027
    Reason
    Add device or group

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
MTK1058/ISK-19
Primary DI / UDI-DI
08053300789450
Basic UDI-DI
805330078CVCFM
Direct Marketing DI
08053300789450
EMDN Code
T0202 Surgical procedural kits (excluding surgical instrument kits)
Device Class
Class IIb

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 bf3154f3-1348-4b65-a4dc-dee752bd5e26 61 fields · synced 25 Oct 2026