Resona A20 Elite Diagnostic Ultrasound System

GUDID 06903053045315

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

General-purpose ultrasound imaging system
Primary Device ID06903053045315
NIH Device Record Key0907d063-ddf6-4fd9-8b55-2d49f5725a75
Commercial Distribution StatusIn Commercial Distribution
Brand NameResona A20 Elite Diagnostic Ultrasound System
Version Model NumberResona A20 Elite
Company DUNS654671304
Company NameShenzhen Mindray Bio-Medical Electronics 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106903053045315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-24
Device Publish Date2025-02-14

Devices Manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

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06903053000031 - Resona Y Diagnostic Ultrasound System 2025-02-24
06903053042161 - Resona A MV Diagnostic Ultrasound System2025-02-24
06903053042284 - Resona A Elite Diagnostic Ultrasound System2025-02-24
06903053042321 - Resona A10S Diagnostic Ultrasound System2025-02-24
06903053044073 - Resona I8W Diagnostic Ultrasound System2025-02-24
06903053044080 - Resona I8 Diagnostic Ultrasound System2025-02-24
06903053044103 - Resona I8 Exp Diagnostic Ultrasound System2025-02-24

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