Skip to content

SLE6000H - Norway (Packaging)

by SLE Ltd United Kingdom EUDAMED

Ref Z6000H EMDN Z1203010503

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05051380009195 Basic UDI-DIDate26 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
SLE6000 Infant Ventilator
Model / Reference
Z6000H
Primary DI / UDI-DI
05051380009195
Basic UDI-DI
B-05051380009195
EMDN Code
Z1203010503 Neonatal/paediatric pulmonary ventilators
Device Class
Class IIb
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
GB-MF-000004155
Authorised representative
Advena Limited MT-AR-000000234

Other devices from SLE Ltd

See all devices from SLE Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Administering Medicine
  • Measuring Function
Other properties (9)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 2c9ac496-e0c2-4d2c-b161-26b5ca9a4e63 61 fields · synced 23 Oct 2026