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CT Enhancement Injector

by Shenzhen Anke High-tech Co., Ltd. 2 variants

Ref ASA-300

Active European Union

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/MDD NumberB-06950743804042 Basic UDI-DI 06950743804042UDI-DIDate26 Mar 2024RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
CT Enhancement Injector
Model / Reference
ASA-300
Primary DI / UDI-DI
06950743804042
Basic UDI-DI
B-06950743804042
EMDN Code
Z11039014 Multiple contrast agent injectors
Device Class
Class IIb
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000016473
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Anke High-Tech Co., Ltd.

See all devices from Shenzhen Anke High-Tech Co., Ltd. →

Properties

  • Administering Medicine

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No