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SLE6000H - Hungary (Packaging)

by SLE Ltd United Kingdom EUDAMED

Ref Z6000H

EMDN Z1203010503

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05051380009164 Basic UDI-DIDate26 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
SLE6000 Infant Ventilator
Model / Reference
Z6000H
Primary DI / UDI-DI
05051380009164
Basic UDI-DI
B-05051380009164
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 05051380009164|B-05051380009164 61 fields · synced 24 Oct 2026