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SOLEA 100 - FULL AUTOMATED COAGULATION ANALYSER, including accessories

by Biolabo EUDAMED

Active European Union

Ref SOLEA 100

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number376017308S1005N Basic UDI-DIDate30 Aug 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
Solea 100
Model / Reference
SOLEA 100
Primary DI / UDI-DI
03760173087228
Basic UDI-DI
376017308S1005N
Direct Marketing DI
03760173087228
EMDN Code
W0202020102 Automated coagulometers
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
FR-MF-000001633

Other devices from Biolabo

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Properties

Show properties
  • Reagent
  • Professional Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No