Qingdao Hisense Medical Equipment Co., Ltd.
Manufacturer and brand owner in Qingdao, Shandong, China. 5 device types, 3 products catalogued, 9 clearances.
Qingdao Hisense Medical Equipment Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Display, Diagnostic Radiology, Transducer, Ultrasonic, Diagnostic and 3 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | Qingdao Hisense Medical Equipment Co.,Ltd. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016696283 |
| FEI number | 3016696283 |
| DUNS | 544312126 |
| Establishment type | Manufacturer |
Location
| City | Qingdao |
|---|---|
| Province | Shandong |
| Address | No. 399 Songling Road, Laoshan District |
| Postal code | 266100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Camera, Television, Surgical, Without Audio | Class 1 | Hisense 8MP LCD Monitor; HME8C32, Hisense 2MP LCD Monitor; HME2C26, Hisense LCD Monitor; HME8C27, Hisense LCD Monitor; HME8C32E, Hisense LCD Monitor; HME8C55U | 2020 | 5 |
| Display, Diagnostic Radiology | Class 2 | Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D, Hisense LCD monitor HMD2G21S, HMD3G21S, LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) | 2022 | 5 |
| System, Imaging, Pulsed Doppler, Ultrasonic | Class 2 | HD25Q, HD25G, HD42S, HD59Plus, L9-3E, HD25S and 153 more | 2022 | 22 |
| System, Imaging, Pulsed Echo, Ultrasonic | Class 2 | HD25Q, HD25G, HD42S, HD59Plus, L9-3E, HD25S and 153 more | 2022 | 37 |
| Transducer, Ultrasonic, Diagnostic | Class 2 | HD25Q, HD25G, HD42S, HD59Plus, L9-3E, HD25S and 153 more | 2022 | 44 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K233841 | 2024-05-16 | IYN | Traditional | This company |
| K233439 | 2024-02-21 | IYN | Traditional | This company |
| K222208 | 2022-11-17 | PGY | Traditional | This company |
| K222132 | 2022-11-08 | PGY | Traditional | This company |
| K221567 | 2022-07-26 | PGY | Traditional | This company |
| K213862 | 2022-06-08 | IYN | Traditional | This company |
| K160347 | 2016-03-03 | PGY | Traditional | This company |
| K152030 | 2015-09-16 | PGY | Traditional | This company |
| K151709 | 2015-07-17 | IYO | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Color Doppler Ultrasound, Portable ultrasound, Aisense series |
|---|---|
| Export markets | Europe, South Africa, USA, Japan |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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