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XL-640 with ISE

by Erba Lachema s.r.o. EUDAMED

Active European Union

Ref INS00007Model XL-640

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8592156CCIN0052SJ Basic UDI-DIDate8 Jul 2026RegisteredStatusActive

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  • Withdrawn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
XL-640, INS00007
Primary DI / UDI-DI
08592156143196
Basic UDI-DI
8592156CCIN0052SJ
EMDN Code
W0201010106 CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
Device Class
Class A
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000024067

Other devices from Erba Lachema s.r.o.

See all devices from Erba Lachema s.r.o. →

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