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Adamonitor SC

by Otsuka Electronics Co., Ltd. Japan EUDAMED

Ref 04582246420010

EMDN B0399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04582246420010 Basic UDI-DIDate28 Feb 2022RegisteredStatusUnknown

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Status not known
  • Not covered

European Union — CE/MDD Status not known

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
04582246420010
Primary DI / UDI-DI
04582246420010
Basic UDI-DI
B-04582246420010
EMDN Code
B0399 Apheresis devices - other
Device Class
Class IIb
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
JP-MF-000001943
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Otsuka Electronics Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 3f9cca16-0034-41bb-b85b-aa166f2c29a7 61 fields · synced 22 Oct 2026