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Single Patient Dialysis Machine DIAMAX WOW

by YAC ELEX Co., LTD. 4 variants

Ref DIAMAX WOW 230V Brazil

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number457131278DIAMAXWOWAZ Basic UDI-DI 04571312780110UDI-DIDate19 May 2025RegisteredStatusActive EUDAMED: not on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Single Patient Dialysis Machine DIAMAX WOW
Model / Reference
DIAMAX WOW 230V Brazil
Primary DI / UDI-DI
04571312780110
Basic UDI-DI
457131278DIAMAXWOWAZ
Direct Marketing DI
04571312780110
EMDN Code
Z12090201 Haemodialysis equipment
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
JP-MF-000046430
Authorised representative
Obelis s.a. BE-AR-000000106

Properties

  • CMR Substance
  • Measuring Function

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No