FDA Registration
Active
🇨🇳 China
WUHAN HUCHUANG UNION TECHNOLOGY CO., LTD.
Reg #: 3023235140
·
FEI: 3023235140
·
Expires 2026
Products
8
Proprietary Names
7
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- WUHAN HUCHUANG UNION TECHNOLOGY CO., LTD.
- Registration Number
- 3023235140
- FEI Number
- 3023235140
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building10, No.818 Gaoxin Avenue
- City
- Wuhan Hubei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K232493
Owner / Operator
- Firm Name
- Wuhan Huchuang Union Technology Co., Ltd.
- Operator Number
- 10084962
- Address
- Building10, No.818 Gaoxin Avenue
- City
- Wuhan
- State
- Hubei
- Postal Code
- 430206
- Country
- CN
- Correspondent
- Yuanyuan Zhan
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Microtools, Assisted Reproduction (Pipettes), Exempt | PUC | Class 2 | Obstetrics/Gynecology | No | 2022-04-20 |
| Microscope And Microscope Accessories, Reproduction, Assisted | MTX | Class 1 | Obstetrics/Gynecology | No | 2024-05-13 |
| Labware, Assisted Reproduction | MQK | Class 2 | Obstetrics/Gynecology | No | 2024-05-13 |
| Accessory, Assisted Reproduction | MQG | Class 2 | Obstetrics/Gynecology | No | 2024-05-13 |
| Micromanipulators And Microinjectors, Assisted Reproduction | MQJ | Class 2 | Obstetrics/Gynecology | No | 2022-12-05 |
| Labware, Assisted Reproduction, Exempt | PUD | Class 2 | Obstetrics/Gynecology | No | 2022-04-20 |
| Assisted Reproduction Laminar Flow Workstation | QKH | Class 2 | Obstetrics/Gynecology | No | 2022-12-05 |
| Accessory, Assisted Reproduction, Exempt | PUB | Class 2 | Obstetrics/Gynecology | No | 2022-04-20 |
Proprietary Names
Assisted Reproduction Micropipettes, Pasteur Pipettes
Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)
Micromanipulation System
IVF Certified Dish, Specimen Containers, Test Tube, Conical Tube, Warming Equipment
Workstation
Incubator DCKMiniA, Incubator CH60R, Incubator CH60L
Droplet preparation Instrument, Incubator DCK900, Incubator DCK1000, Incubator DCK6, Incubator DCK10,
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device