Skip to content

Dbb-Exa Es

by Nikkiso Co., Ltd.

Ref DBB-EXA ESModel DBB-EXA

Dbb-Exa Es is a Class IIb device made by Nikkiso Co., Ltd., registered in EUDAMED on 25 May 2026 (Basic UDI-DI 4987671HD-EqA2P), active as of 24 Oct 2026.

Active European Union

CE MDR CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number4987671HD-EqA2P Basic UDI-DI Date25 May 2026RegisteredStatusActive
European UnionCE/MDR Number4987671HD-EqA2P Basic UDI-DI Date25 May 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD, CE/MDR Active

Specification

EUDAMED

Device name
Hemodialysis Equipment DBB-EXA
Hemodialysis Equipment
Model / reference
DBB-EXA, DBB-EXA ES
Primary DI / UDI-DI
04987671600080, 04987671600011
Basic UDI-DI
4987671HD-EqA2P, B-04987671600011
Direct marketing DI
04987671600080
EMDN code
Z12090201 Haemodialysis equipment
Device class
Class IIb
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

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

Similar devices in this category

Other devices filed under HAEMODIALYSIS EQUIPMENT.

Other devices from Nikkiso Co., Ltd.

See all devices from Nikkiso Co., Ltd. →

Properties

  • Measuring function
Other properties (13, all answered No)