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CardioGen-82 Infusion System, Model 1701

by E-Z-EM, Inc. A subsidiary of Bracco Diagnostics Inc. a.d.b.a. Bracco Diagnostics Inc. EUDAMED

Active European Union

Ref 001701

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-30815112021321 Basic UDI-DIDate26 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

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.

Specification

EUDAMED

Device Name
CardioGen-82 Infusion System, Model 1701
Model / Reference
001701
Primary DI / UDI-DI
30815112021321
Basic UDI-DI
B-30815112021321
EMDN Code
Z12030301 Infusion pumps
Device Class
Class IIb
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
US-MF-000008497
Authorised representative
ACIST Europe BV NL-AR-000002151

Properties

  • Administering Medicine
  • Measuring Function

Other properties (11)

  • 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
  • Incorporates Medicinal Product: No