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BIO SOLEA 4 - COAGULOMETER 4 CHANNELS, including accessories

by Biolabo France EUDAMED

Ref BIOSOLEA 4Model BIO SOLEA 2 EMDN W0202020101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number376017308BSS6 Basic UDI-DIDate1 Jul 2025RegisteredStatusActive

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  • Withdrawn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 · synced 22 Oct 2026

Device Name
Coagulometer
Model / Reference
BIO SOLEA 2, BIOSOLEA 4
Primary DI / UDI-DI
03760173087136
Basic UDI-DI
376017308BSS6
Direct Marketing DI
03760173087136
EMDN Code
W0202020101 Semi-automated coagulometers
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000001633

Other devices from Biolabo

See all devices from Biolabo →

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 (1)

  • EUDAMED b7a49182-6bf1-45bb-a7d3-7dbbacdfe3ae 61 fields · synced 22 Oct 2026