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Sensitex Non-lubricated

by Richter Rubber Technology Sdn Bhd EUDAMED

Active European Union

Ref QA-280

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMY26/00000108 Date6 Feb 2026IssuedStatusActive expires 6 Feb 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MY26/00000108 Issued

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    6 Feb 2026
    Expires
    6 Feb 2031

Specification

EUDAMED

Device Name
Non Sterile Natural Latex Probe Cover
Model / Reference
QA-280
Primary DI / UDI-DI
09556807602486
Basic UDI-DI
9556807PC001YP
Direct Marketing DI
09556807602486
EMDN Code
Z11049085 Various ultrasound instruments - consumables
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
MY-MF-000023324
Authorised representative
rrt Vertrieb und Service GmbH DE-AR-000021443

Other devices from Richter Rubber Technology Sdn. Bhd.

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Properties

  • Contains Latex

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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