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Autolyser

by Biotecnica Instruments S.r.l. EUDAMED

Active European Union

Ref AUTOLYSER-B-C, AUTOLYSER-C-E, AUTOLYSER-B-E, AUTOLYSER-A-B, AUTOLYSER-A-C, AUTOLYSER-C-FModel AUTOLYSER

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0803362296359UG Basic UDI-DIDate9 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
AUTOLYSER, AUTOLYSER-B-C, AUTOLYSER-C-E, AUTOLYSER-B-E, AUTOLYSER-A-B, AUTOLYSER-A-C, AUTOLYSER-C-F
Primary DI / UDI-DI
08033622963769, 08033622964100, 08033622963783, 08033622963714, 08033622963721, 08033622965039
Basic UDI-DI
0803362296359UG
Direct Marketing DI
08033622963769
08033622964100
08033622963783
08033622963714
08033622963721
08033622965039
EMDN Code
W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
IT-MF-000008115

Other devices from Biotecnica Instruments S.r.l.

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Properties

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