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KAO - Caolino / Kaolin (for Fibrinogen)

by Sanymed s.a.s. EUDAMED

Active European Union

Ref EMS143

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08056216730301 Basic UDI-DIDate20 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
KAO - Caolino / Kaolin (for Fibrinogen) Coagulation R1: 8x1ml
Model / Reference
EMS143
Primary DI / UDI-DI
08056216730301
Basic UDI-DI
B-08056216730301
EMDN Code
W0103020201 Fibrinogen assays (factor i)
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000026483

Other devices from Sanymed s.a.s.

See all devices from Sanymed s.a.s. →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No