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Telo Isolam. Vertic. CM250X330 Iodato

by Betatex SpA Italy EUDAMED

Ref MTT0590-IModel TELERIA SPECIALISTICA CON ANTIBATTERICO EMDN T02010102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805330078STDHZ Basic UDI-DIDate18 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 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
  • CVD001823 Issued

    Technical documentation EU MDR

    Notified body
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    2 Nov 2023
    Expires
    23 Oct 2027

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Teleria Specialistica Con Antibatterico
Model / Reference
TELERIA SPECIALISTICA CON ANTIBATTERICO, MTT0590-I
Primary DI / UDI-DI
08053807813108
Basic UDI-DI
805330078STDHZ
Direct Marketing DI
08053807813108
EMDN Code
T02010102 Incision drapes, with antibacterial agent
Device Class
Class III
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
  • Incorporates Medicinal Product
Other properties (11)
  • 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

Sources (1)

  • EUDAMED ea24c057-c2f2-48e5-91a8-5b1fdb637433 61 fields · synced 24 Oct 2026