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sthemA 801 / HERA

by Arteion S.A.S France EUDAMED

Ref 58879 / 21302126, 58879Model sthemA 801 / HERA - Haematology Analyser EMDN W0202010102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-03760356780021 Basic UDI-DIDate8 Mar 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Trade Name
sthemA 801 / HERA
sthemA 801
Model / Reference
sthemA 801 / HERA - Haematology Analyser, 58879 / 21302126, 58879
Primary DI / UDI-DI
03760356780021
Basic UDI-DI
B-03760356780021, 376035678HAEMA0001XY
Direct Marketing DI
03760356780021
EMDN Code
W0202010102 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 samples/hr)
Device Class
Class IVD General
Class B
Market of Registration
Ireland
France

Manufacturer details

EUDAMED SRN
FR-MF-000035476

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED 3c8be809-a9f3-4188-ad4d-52b17c5022f3 61 fields · synced 22 Oct 2026
  • EUDAMED 03760356780021|376035678HAEMA0001XY 61 fields · synced 24 Oct 2026