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Dbb-Exa

by Nikkiso Co., Ltd. Japan EUDAMED

Ref DBB-EXA

EMDN Z12090201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number4987671HD-EqA2P Basic UDI-DIDate25 May 2026RegisteredStatusActive
European UnionCE/MDR Number4987671HD-EqA2P Basic UDI-DIDate25 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Hemodialysis Equipment DBB-EXA
Hemodialysis Equipment
Model / Reference
DBB-EXA
Primary DI / UDI-DI
04987671600004, 04987671600073
Basic UDI-DI
4987671HD-EqA2P, B-04987671600004
Direct Marketing DI
04987671600004
04987671600073
EMDN Code
Z12090201 Haemodialysis equipment
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000019276
Authorised representative
NIKKISO Medical Europe GmbH DE-AR-000042794

Other devices from Nikkiso Co., Ltd.

See all devices from Nikkiso Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (3)

  • EUDAMED 28c0988c-d450-401e-a69d-a5b78224106d 61 fields · synced 22 Oct 2026
  • EUDAMED 04987671600073|4987671HD-EQA2P 61 fields · synced 14 Oct 2026
  • EUDAMED 04987671600004|B-04987671600004 61 fields · synced 24 Oct 2026