FDA Registration
Active
🇨🇳 China
Qingdao Hisense Medical Equipment Co.,Ltd.
Reg #: 3016696283
·
FEI: 3016696283
·
Expires 2026
Products
5
Proprietary Names
254
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Qingdao Hisense Medical Equipment Co.,Ltd.
- Registration Number
- 3016696283
- FEI Number
- 3016696283
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 399 Songling Road, Laoshan District
- City
- Qingdao Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222132
Owner / Operator
- Firm Name
- Qingdao Hisense Medical Equipment Co.,Ltd.
- Operator Number
- 10062879
- Address
- No. 399 Songling Road, Laoshan District
- City
- Qingdao
- State
- Shandong
- Postal Code
- 266100
- Country
- CN
- Correspondent
- Mengmeng Dong
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Display, Diagnostic Radiology | PGY | Class 2 | Radiology | No | 2022-12-06 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2024-02-26 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2024-02-26 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2024-02-26 |
| Camera, Television, Surgical, Without Audio | FWB | Class 1 | General, Plastic Surgery | No | 2020-03-12 |
Proprietary Names
Hisense LCD monitor HMD2G21S, HMD3G21S
P4-1E
HD35
P4-1EB
HD30T
HD25E
HD60E
HD50G
HD45
HD20T
C5-1E
L12-4L
HD55Plus
HD50
HD30
HD42Q
HD40
HD25EXP
L15-5EB
HD45Q
E9-4E
HD40Q
HD30Q
L14-6E
HD25Q
HD42
L9-3E
HD25G
HD42S
HD42G
HD60
HD40E
P4-1L
HD62Pro
MC11-3A
HD48Plus
HD35S
HD20
HD58
L15-5EL
L9-3A
DC7-2A
HD48G
ECL11-4E
HD58EXP
HD58Pro
E9-3E
SC7-1E
SC8-2E
E9-4EL
HD55E
HD45S
HD45T
HD30E
HD30EXP
P4-1EL
HD55
HD35Plus
P5-1A
HD20E
P8-2EJ
HD60S
HD50E
HD59
HD45E
HD20Pro
HD20S
HD40Plus
HD59EXP
HD60EXP
L12-3EB
DC6-2A
HD42T
HD25Pro
E9-4L
C5-2A
HD50T
HD55S
HD25T
HD40G
HD55T
HD48E
HD59Pro
HD30G
HD55G
HD62EXP
HD30S
HD25
HD50Q
HD62
HD60G
HD60Pro
HD35G
HD50S
L12-3E
HD20G
HD48Q
HD59Plus
HD45Plus
HD48
HD20EXP
HD58Plus
HD45G
HD42E
DE10-3E
L15-5E
HD40S
HD42Plus
HD35Q
HD30Pro
HD20Q
HD35T
HD60T
HD60Q
HD35E
HD55Q
HD48S
E9-4B
HD25S
HD40T
C5-2L
HD62Plus
HD50Plus
HD48T
Hisense 8MP LCD Monitor; HME8C32
Hisense 2MP LCD Monitor; HME2C26
Hisense LCD Monitor; HME8C27
Hisense LCD Monitor; HME8C55U
Hisense LCD Monitor; HME8C32E
HD80M
HD72G
HD70
HD75M
HD75G
HD80Pro
HD82
HD70T
HD78
HD88EXP
HD70S
XP5-1E
HD82Q
HD90Plus
HD78Q
HD80G
HD80
HD88S
HD82S
HD85M
HD82T
HD72S
HD82G
HD70Q
HD82M
HD85T
HD80S
HD90
HD70Pro
HD86
HD90EXP
HD80Q
HD72Plus
HD72
HD70G
HD85Q
HD85Plus
HD80T
HD88G
HD86T
HD80Plus
HD78Pro
HD70EXP
HD85E
DC7-2E
HD86E
HD75E
HD75Pro
HD86S
HD78EXP
HD78T
HD86G
HD75T
HD90Pro
HD85G
HD70M
HD82Pro
HD86Plus
HD72EXP
HD86Pro
HD70E
HD80EXP
HD72M
HD85Pro
HD72Pro
HD78M
HD85
HD78S
HD78E
HD86M
HD78Plus
HD82E
HD86EXP
HD88M
HD78G
HD88T
HD75Plus
HD82Plus
HD88Q
HD88
HD75EXP
HD72E
HD70Plus
HD72Q
HD80E
HD75Q
HD75
L21-9E
HD88Plus
HD82EXP
HD85S
HD85EXP
HD72T
HD88E
HD88Pro
HD75S
HD86Q
HD62 Exp
HD59 Exp
HD58 Plus
HD61 Plus
HD62 Pro
P8-2E
HD58 Exp
HD61
HD38
HD38Q
HD61 Exp
HD60 Exp
HD61 Pro
C6-1S
HD60 Pro
HD38Plus
HD38G
HD38T
HD62 Plus
HD38S
HD60 Plus
HD58 Pro
MC9-4A
HD38E
HD59 Plus
HD59 Pro
Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D
LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)
Establishment Types
Manufacture Medical Device