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HFL38xi/13-6 MHz

by Fujifilm Sonosite, Inc.

Ref P30365-02, P30366-02Model TRANSDUCER, HFL38XI/13-6 MHZ

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08415171HFL38XI9C Basic UDI-DI Date28 Oct 2025RegisteredStatusActive

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  • Withdrawn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
Transducer, HFL38XI/13-6 Mhz
Model / Reference
TRANSDUCER, HFL38XI/13-6 MHZ, P30365-02, P30366-02
Primary DI / UDI-DI
00841517111137, 00841517111120
Basic UDI-DI
08415171HFL38XI9C
EMDN Code
Z110402010101 Two–dimensional linear–array transcutaneous ultrasound probes
Device Class
Class IIa
EU market of registration
France

Manufacturer details

EUDAMED SRN
US-MF-000001075
Authorised representative
Fujifilm Sonosite B.V. NL-AR-000000046

Other devices from Fujifilm Sonosite, Inc.

See all devices from Fujifilm Sonosite, 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