HERA Z30 Diagnostic Ultrasound System

GUDID 08809944936220

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system
Primary Device ID08809944936220
NIH Device Record Key5b4f7a63-57d7-4b29-99bb-0c0ab1616a56
Commercial Distribution StatusIn Commercial Distribution
Brand NameHERA Z30 Diagnostic Ultrasound System
Version Model NumberHERA Z30
Company DUNS687785691
Company NameSAMSUNG MEDISON CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809944936220 [Primary]

FDA Product Code

QIHAutomated Radiological Image Processing Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-28
Device Publish Date2026-01-20

Devices Manufactured by SAMSUNG MEDISON CO., LTD.

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08800290027297 - PA2-9S2026-01-28
08800290027334 - LA2-9Sn2026-01-28
08800290027365 - CA3-10An2026-01-28
08800290031522 - HERA Z20e Diagnostic Ultrasound System2026-01-28
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