Skip to content

Ecodent Rolls XL

by BABGENCEL GmbH EUDAMED

Active European Union

Ref 20EW01-PE113R114Model 20EW01

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426071005EW0000000PQ Basic UDI-DIDate11 May 2026RegisteredStatusActive

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  • Withdrawn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)
  • MDR00145-A Issued

    Quality management system EU MDR

    Notified body
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    12 Jun 2025
    Expires
    3 Feb 2030

Specification

EUDAMED

Device Name
Alcohol Based Disinfection Wipes
Model / Reference
20EW01, 20EW01-PE113R114
Primary DI / UDI-DI
42607100538028
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000019691

Other devices from BABGENCEL GmbH

See all devices from BABGENCEL GmbH →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • 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 e3a90210-570e-493d-9bc7-84e5156ab859 61 fields · synced 25 Oct 2026