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CUA0903PF

by CU Medical Systems, Inc.

Ref CUA0903PFModel CUA1007S

Active European Union

CE MDR CE MDD

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 NumberB-08809435482083 Basic UDI-DI 08809435482083UDI-DIDate18 Sep 2026RegisteredStatusActive
European UnionCE/MDD NumberB-08809435482083 Basic UDI-DI 08809435482083UDI-DIDate18 Sep 2026RegisteredStatusActive

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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Device Name
Defibrillation Pads/Electrodes
Model / Reference
CUA0903PF, CUA1007S
Primary DI / UDI-DI
08809435482083
Basic UDI-DI
B-08809435482083, 880943548Pads/Electrode9Z
EMDN Code
C020401, Z12030585
Device Class
Class IIb
Class I
EU market of registration
Italy
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000018333
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from CU Medical Systems, Inc.

Properties

Other properties (13)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No