Skip to content

AltoStar® Automation System AM16

by Hamilton Bonaduz AG United States EUDAMED

Ref 806160

EMDN W02060199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number07630032680616085 Basic UDI-DIDate4 Oct 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
806160
Primary DI / UDI-DI
07630032635456
Basic UDI-DI
07630032680616085, 76300326806160LX
Direct Marketing DI
07630032635456
EMDN Code
W02060199 Robotic sample processing systems - other
Device Class
Class A
Market of Registration
Germany
Austria

Manufacturer details

EUDAMED SRN
CH-MF-000013585
Authorised representative
Johner Medical GmbH DE-AR-000011832

Properties & raw data

Show properties, registry sources and raw records
  • Surgical Instrument
  • New Device YesEUDAMEDNoEUDAMED
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No

Sources (2)

  • EUDAMED ab990dde-84d0-42f6-b490-ffe5fcb9dd36 61 fields · synced 22 Oct 2026
  • EUDAMED 07630032635456|76300326806160LX 61 fields · synced 6 Oct 2026