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Sign in to claim this brandQingdao Hisense Medical Equipment Co., Ltd.
China·CN-MF-000007334
Last updated May 23, 2026
What Qingdao Hisense Medical Equipment Co., Ltd. makes
The company manufactures handheld extracorporeal ultrasound imaging transducers, general-purpose ultrasound imaging systems, and rectal/vaginal ultrasound imaging transducers. It also produces monochrome image display units designed for medical imaging applications.
These devices are classified under Class I, Class II, and Class IIa regulations. They are listed in the EU’s eudamed registry, the FDA’s 510(k) and UDI systems, and the company is based in China.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Qingdao Hisense Medical Equipment Co., Ltd. manufacture?
Qingdao Hisense Medical Equipment Co., Ltd. specializes in ultrasound-related medical devices. Their portfolio includes handheld extracorporeal ultrasound imaging transducers, general-purpose ultrasound imaging systems, rectal/vaginal ultrasound imaging transducers, and monochrome image display units. These devices are designed for diagnostic imaging applications, particularly in ultrasound technology.
Where is Qingdao Hisense Medical Equipment Co., Ltd. based?
The company is headquartered in Qingdao, China. This location reflects its primary operational base for manufacturing and distributing its medical imaging devices.
In which regulatory registries are Qingdao Hisense Medical Equipment Co., Ltd.’s devices listed?
The company’s devices are listed in multiple global regulatory databases, including the EU’s eudamed registry and the U.S. FDA’s 510(k) premarket notification system as well as the FDA’s Unique Device Identifier (UDI) database. These registries help track and verify the compliance and availability of their medical devices in different markets.
How are Qingdao Hisense Medical Equipment Co., Ltd.’s devices classified under regulatory standards?
The devices manufactured by Qingdao Hisense Medical Equipment Co., Ltd. fall under Class I, Class II, and Class IIa regulatory classifications. These classifications determine the level of scrutiny and regulatory oversight required, with Class I being the lowest risk and Class IIa representing moderate risk based on their intended use and potential health impact.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- China
- Address
- No. 399, Songling Road, Laoshan District, Qingdao, Shandong, China
- Website
- hisense.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Guangbin Wang
- EUDAMED SRN
- CN-MF-000007334
- FDA FEI Number
- —
- DUNS Number
- 544312126
Catalogue (184)
Page 2 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HD60 Series Ultrasound Diagnostic System | K233439 | FDA 510(k) | Class II | Active |
| HD60 Series Ultrasound Diagnostic System | K213862 | FDA 510(k) | Class II | Active |
| HD80 Series Ultrasound Diagnostic System | K233841 | FDA 510(k) | Class II | Active |
| Hisense LCD monitor HMD2G21S, HMD3G21S | K222132 | FDA 510(k) | Class II | Active |
| Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) | K152030 | FDA 510(k) | Class II | Active |
| Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 | K160347 | FDA 510(k) | Class II | Active |
| Hi-Light Diagnostic Ultrasound Systems | K151709 | FDA 510(k) | Class II | Active |
| LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) | K221567 | FDA 510(k) | Class II | Active |
| Hisense | HD75EXP | EUDAMED | Class IIa | Active |
| Hisense | HD42E | EUDAMEDFDA UDI | Class IIa | Active |
| Hisense | HD58 Plus | EUDAMEDFDA UDI | Class IIa | Active |
| Hisense | HD35T | EUDAMEDFDA UDI | Class IIa | Active |
| Hisense | HD58Pro | EUDAMED | Class IIa | Active |
| Hisense | HMD5G21S | EUDAMEDFDA UDI | Class I | Active |
| Hisense | HD85T | EUDAMED | Class IIa | Active |
| Hisense | HD25Q | EUDAMED | Class IIa | Active |
| Hisense | HD88Q | EUDAMED | Class IIa | Active |
| Hisense | HME8C55U | EUDAMED | Class I | Active |
| Hisense | HD86EXP | EUDAMED | Class IIa | Active |
| Hisense | HD60EXP | EUDAMED | Class IIa | Active |
| Hisense | HD60 | EUDAMEDFDA UDI | Class IIa | Active |
| Hisense | HD85EXP | EUDAMED | Class IIa | Active |
| Hisense | HD45Q | EUDAMED | Class IIa | Active |
| Hisense | HD61 Pro | EUDAMEDFDA UDI | Class IIa | Active |
| Hisense | HD25G | EUDAMED | Class IIa | Active |
| Hisense | HD45G | EUDAMED | Class IIa | Active |
| Hisense | HD85Pro | EUDAMED | Class IIa | Active |
| Hisense | Aisense E60S | EUDAMED | Class IIa | Active |
| Hisense | HD48Q | EUDAMED | Class IIa | Active |
| Hisense | HD60T | EUDAMED | Class IIa | Active |
| Hisense | HD55 | EUDAMED | Class IIa | Active |
| Hisense | HD70E | EUDAMED | Class IIa | Active |
| Hisense | HME8C55S | EUDAMED | Class I | Active |
| Hisense | HD42G | EUDAMEDFDA UDI | Class IIa | Active |
| Hisense | HD20EXP | EUDAMED | Class IIa | Active |
| Hisense | Aisense E60 | EUDAMED | Class IIa | Active |
| Hisense | HD78 | EUDAMEDFDA UDI | Class IIa | Active |
| Hisense | HD30S | EUDAMED | Class IIa | Active |
| Hisense | HD80Plus | EUDAMED | Class IIa | Active |
| Hisense | HD72E | EUDAMED | Class IIa | Active |
| Hisense | HD82T | EUDAMED | Class IIa | Active |
| Hisense | HD30EXP | EUDAMED | Class IIa | Active |
| Hisense | HD55G | EUDAMED | Class IIa | Active |
| Hisense | HD75S | EUDAMED | Class IIa | Active |
| Hisense | HMD6C30D | EUDAMEDFDA UDI | Class I | Active |
| Hisense | HD88 | EUDAMED | Class IIa | Active |
| Hisense | HD62 Exp | EUDAMEDFDA UDI | Class IIa | Active |
| Hisense | HMD4C27S | EUDAMEDFDA UDI | Class I | Active |
| Hisense | HD38Q | EUDAMEDFDA UDI | Class IIa | Active |
| Hisense | HD35Q | EUDAMEDFDA UDI | Class IIa | Active |
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