QINGDAO HISENSE MEDICAL CO., LTD.

FDA Device Registration & Listing · Qingdao Shandong, CN · Registration 3040391009

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
3040391009
FEI Number
3040391009
Entity Name
QINGDAO HISENSE MEDICAL CO., LTD.
City/State/Country
Qingdao Shandong, CN
Establishment Address
No. 399 Songling Road, Laoshan District, Qingdao Shandong 266100, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Qingdao Hisense Medical Co., Ltd. (Owner Number: 10093827)
Owner / Operator Contact Address
No. 399 Songling Road, Laoshan District, Qingdao, CN-SD 266100, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K233439
PMA Number
N/A

All Registered Proprietary Names

HD88T HD70E HD72Q HD80 HD80G HD80S HD90EXP HD72M HD90Pro HD86M HD72T HD72EXP P5-1A HD75T HD82G MC11-3A HD85T HD78G HD86T HD78Pro HD90Plus L9-3E HD82Pro HD82 HD82Plus HD82Q HD82S E9-3E HD85Pro HD78S HD88Pro HD82T HD80EXP HD70Q L14-6E ECL11-4E HD86S HD85S HD85EXP HD70EXP HD86Pro L12-3EB DC7-2E HD70G HD80T HD75 HD85 HD70 SC8-2E L15-5EB HD75EXP HD86Q HD70M HD75Pro HD75S E9-4E HD78M DC7-2A C5-1E HD82E DE10-3E HD80E HD78Plus HD88Q HD85G HD78EXP HD86Plus HD75M HD75Q HD90 L15-5E HD85M HD72E HD82M HD75Plus P4-1EL HD80Q HD86E HD70Pro HD72S HD75G HD70T HD86EXP HD88 HD88EXP HD88Plus HD85Plus L12-3E E9-4EL L21-9E HD85Q HD80Plus P4-1EB HD86 HD80M HD78E HD70Plus HD86G L15-5EL HD85E HD88M HD82EXP HD78Q HD80Pro HD78T HD88S HD72 HD78 HD70S SC7-1E HD88E HD75E HD72G HD88G P8-2EJ HD72Plus XP5-1E HD25Pro HD40T L15-5E HD42T P4-1L L9-3E HD55 P5-1A HD20S HD25E HD30Q HD50Plus HD42 P8-2EJ DC7-2A L12-4L HD45Q SC7-1E HD40 L15-5EB HD58 HD20E HD55Q HD42S HD58Plus HD60E HD20Q HD48Q HD45T HD30G HD42E HD35 HD35G HD58Pro HD60Q HD48S P4-1EL HD55G DE10-3E HD45E L9-3A HD48T HD60Pro SC8-2E HD25T L14-6E HD35Q E9-3E HD48E HD40S HD50S HD62 HD55Plus HD42Q E9-4L HD40Plus HD45Plus HD35E C5-1E HD20T P4- 1E HD50G HD59Pro HD60T HD62Plus HD30 DC6-2A HD20G HD59Plus ECL11-4E HD30E E9-4E HD42G HD50Q HD50 HD25G HD55E HD30S HD20 HD48 HD45S HD59EXP HD25Q HD55S HD45G HD42Plus HD40G HD48Plus C5-2A HD35Plus HD30T L12-3E HD60G HD50T HD58EXP HD60S HD60EXP P4-1EB HD30EXP HD48G L12- 3EB HD62EXP HD35S HD45 HD35T C5-2L HD25EXP HD62Pro L15-5EL HD59 HD20Pro HD55T HD40Q E9-4B MC11-3A HD20EXP HD40E HD25S E9-4EL HD50E HD60 HD25 HD30Pro

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 2025-09-09
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-09-09
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-09-09
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-08-22
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-08-22
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-08-22

Official Correspondent

Guangbin Wang

US Agent Details

Dennis Xu Email: ybx99@yahoo.com Phone: (919) 8590478

Related Public Records

Same Entity

Qingdao Hisense Medical 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 3040391009. Last updated year: 2026. Please use registration number 3040391009 when referencing this establishment in official correspondence.
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