FDA Registration
Active
🇨🇳 China
Fetal Doppler model TK-T805CR.TK-T805R.TK-T805C.TK-T805
Reg #: 3017207990
·
FEI: 3017207990
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHENZHEN YUEZHONGXING TECHNOLOGY CO.,LTD
- Registration Number
- 3017207990
- FEI Number
- 3017207990
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building E105,Haowei Industrial park,No.8Qinglan 1st Road,Zhukeng Community,Long Tian street,Pingshan District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K211940
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 |
|---|---|---|---|---|---|
| Monitor, Ultrasonic, Fetal | KNG | Class 2 | Obstetrics/Gynecology | No | 2022-03-04 |
Proprietary Names
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
Establishment Types
Repack or Relabel Medical Device