FDA Registration
Active
🇨🇳 China
SHENZHEN YUEZHONGXING TECHNOLOGY CO.,LTD
Reg #: 3017207990
·
FEI: 3017207990
·
Expires 2026
Products
10
Proprietary Names
25
Establishment Types
3
Classifications
10
Registration Details
- Registration Name
- SHENZHEN YUEZHONGXING TECHNOLOGY CO.,LTD
- Registration Number
- 3017207990
- FEI Number
- 3017207990
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3 / F, Building 4, Kai Meng Zhigu Industrial Park, No. 463 Longshan 4th Road, Dayawan District
- City
- Huizhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K233799
Owner / Operator
- Firm Name
- Shenzhen Yuezhongxing Technology Co.,Ltd
- Operator Number
- 10082993
- Address
- Building E105,Haowei Industrial park,No.8Qinglan 1st Road,Zhukeng Community,Long Tian street,Pingshan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518015
- Country
- CN
- Correspondent
- Yuchao Chen
US Agent
- Business Name
- WISELINK MEDICAL INC.
- Contact Name
- Nelson Xie
- Address
- 666 Old Country Rd Ste 201 Garden City Ny 11530
- City
- Garden City
- State
- NY
- ZIP
- 11530
- Country
- US
- [email protected]
- Phone
- 631 2558110
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2022-01-21 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2024-03-24 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2022-03-04 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2022-12-06 |
| Irrigator, Powered Nasal | KMA | Class 1 | Ear, Nose, Throat | No | 2022-05-27 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2022-12-06 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2022-03-04 |
| Monitor, Ultrasonic, Fetal | KNG | Class 2 | Obstetrics/Gynecology | No | 2022-03-04 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2025-11-19 |
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2022-12-06 |
Proprietary Names
333 Pulse Oximeter
Aleshon, Finger Oximeter, Model 333
Aleshon, Finger Oximeter, Model 331
Aleshon, Finger Oximeter, Model 321
Wrist Blood Pressure Monitor, Model: 223BT
Wrist Blood Pressure Monitor, Model: W1681R
Wrist Blood Pressure Monitor, Model: 222BT
Wrist Blood Pressure Monitor, Model: W1681BL
Wrist Blood Pressure Monitor, Model: 223
Wrist Blood Pressure Monitor, Model: W1681BT
Wrist Blood Pressure Monitor, Model: 222
Aleshon Portable Mesh Nebulizer (Home-use) 506, 507, 508
HEARING AID, MS-909D/ MS-909A/ MS-918D/ MS-918A/ MS-919D/ MS919A/ MS929D/ MS-929A
Electric Nasal Irrigator BQ003A,BQ003B,BQ003,1001,1002,1003,1004
Wrist Blood Pressure Monitor W203,W202,W1681,W1681BL,W202BL,W203BL
Inspiratory muscle trainer,Breatory
Aleshon Ultrasonic Mesh Nebulizer 501/ 502/ 503 /504 /505
Fetal Doppler model TK-T805CR.TK-T805R.TK-T805C.TK-T805
Aleshon Fetal Doppler TK-T802CR.TK-T802R.TK-T802C.TK-T802.TK-T806CR.TK-T806R.TK-T806C.TK-T806
Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683
Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681
Arm Blood Pressure Monitor, Model Name:121, Arm Blood Pressure Monitor, Model Name: 121R
TempBuddy Non-Contact Infrared Forehead Themometer ZTP-800
HEARING AID, AIR-CONDUCTION, PRESCRIPTION NJ-816D NJ-816A NJ-916D NJ-916A
Upper Arm Electronic Blood Pressure Monitor
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Repack or Relabel Medical Device