SHENZHEN DELICA MEDICAL EQUIPMENT CO., LTD.

FDA Device Registration & Listing · SHENZHEN Guangdong, CN · Registration 3006441164

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006441164
FEI Number
3006441164
Entity Name
SHENZHEN DELICA MEDICAL EQUIPMENT CO., LTD.
City/State/Country
SHENZHEN Guangdong, CN
Establishment Address
18F, Building B, High-tech park, Guangqiao Road, Tianliao Community,, Yutang Street, Guangming District,, SHENZHEN Guangdong 518107, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SHENZHEN DELICA MEDICAL EQUIPMENT CO., LTD. (Owner Number: 9081823)
Owner / Operator Contact Address
18F, Building B, High-tech park, Guangqiao Road, Tianliao Community, Yutang Street, Guangming District,, SHENZHEN, CN-GD 518107, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K122710
PMA Number
N/A

All Registered Proprietary Names

Transcranial Doppler Ultrasound System Transcranial Doppler Ultrasound System Transcranial Doppler Ultrasound System Transcranial Doppler Ultrasound System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2006-11-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2006-11-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-07-12
OQQ Diagnostic Ultrasonic Transducer, Robotic Radiology Class 2 892.1570 2022-07-12
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-07-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-06-18
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2019-06-18
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2019-06-18
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2019-06-18
OQQ Diagnostic Ultrasonic Transducer, Robotic Radiology Class 2 892.1570 2019-06-18
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2013-02-20
OQQ Diagnostic Ultrasonic Transducer, Robotic Radiology Class 2 892.1570 2013-02-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2013-02-20

Official Correspondent

No official correspondent registered.

US Agent Details

Scott Bednar Business: QA/RA CONSULTING GROUP, INC. Email: sbednar@qaraconsultinggroup.com Phone: (412) 4188066

Related Public Records

Same Entity

SHENZHEN DELICA MEDICAL EQUIPMENT CO., LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K191007 Supersonic Imagine Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems 2019-10-25
K974588 Rimed , Ltd. INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD 1998-08-07
K142628 Siemens Medi Cal Solutions, Inc. Acuson SC2000 Diagnostic Ultrasound System 2014-10-10
K132171 Supersonic Imagine AIXPLORER 2013-09-24
K222441 Bk Medical Aps Ultrasound System 2300 2022-12-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0189-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Z-0190-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Z-0191-2022 FujiFilm Healthcare Americas Corporation 2
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Z-0192-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Z-1884-2024 FUJIFILM Healthcare Americas Corporation 2
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006441164. Last updated year: 2026. Please use registration number 3006441164 when referencing this establishment in official correspondence.
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