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Hayllo Universal

by BABGENCEL GmbH Germany EUDAMED

Ref 21TR01-AG0015000Model 21TR01

EMDN D0902

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426071005TRC00000097 Basic UDI-DIDate11 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • 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 · synced 22 Oct 2026

Device Name
Disinfection Concentrate
Model / Reference
21TR01, 21TR01-AG0015000
Primary DI / UDI-DI
42607100506270
Basic UDI-DI
426071005TRC00000097
EMDN Code
D0902 Associated ammonium salts for the disinfection of medical devices
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000019691

Other devices from BABGENCEL GmbH

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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 942b75fa-362f-4098-8695-24d625fd47ba 61 fields · synced 22 Oct 2026