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SonoSite Edge II P30380-15

by Fujifilm Sonosite, Inc.

Ref P30380-02, P30380-15Model SONOSITE EDGE II ULTRASOUND SYSTEM, SONOSITE EDGE II ULTRASOUND SYSTEM, 4.1

Withdrawn Withdrawn in European Union.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00841517107925 Basic UDI-DI Date22 Oct 2025RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number00841517109776 UDI-DI Date1 Aug 2023ListedStatusListed GUDID: in commercial distribution

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
SonoSite Edge II
SonoSite Edge
Generic Name
General-purpose ultrasound imaging system
Device Name
Sonosite Edge II Ultrasound System, 4.1
Model / Ref / Catalog
P30380-15, P30380-02, SONOSITE EDGE II ULTRASOUND SYSTEM, 4.1, P30380
Primary DI / UDI-DI
00841517109776, 00841517107925
Basic UDI-DI
B-00841517107925, B-00841517109776
510(k) Number
FDA Product Code
ITX, IYN, IYO
EMDN Code
Z11040103 Portable ultrasound scanners
GMDN Term
General-purpose ultrasound imaging system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1570, 892.1550, 892.1560
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K153626)

Cleared under the same submission (K162045)

Other devices from Fujifilm Sonosite, Inc.

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Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No