FDA Registration
Active
🇨🇳 China
Pulse Oximeter (WS20A), Pulse Oximeter (WS10A)
Reg #: 3011353016
·
FEI: 3011353016
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3011353016
- FEI Number
- 3011353016
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Accurate Industrial Park, No.108, Zhixian Road, Xuelian Community, Xueshi Street of Yuelu District
- City
- Changsha Hunan
- Country
- CN
Owner / Operator
- Firm Name
- Hunan Accurate Bio-Medical Technology Co., Ltd.
- Operator Number
- 10048204
- Address
- Accurate Industrial Park, No.108, Zhixian Road, Xuelian Community, Xueshi Street of Yuelu District
- City
- Changsha
- State
- Hunan
- Postal Code
- 410208
- Country
- CN
- Correspondent
- Li Zhang
US Agent
- Business Name
- Dynasty Medical Consulting Inc.
- Contact Name
- Linda Chen
- Address
- 302 Round Lake Dr
- City
- Rosenberg
- State
- TX
- ZIP
- 77469
- Country
- US
- [email protected]
- Phone
- 832 3809688
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2015-01-04 |
Proprietary Names
Pulse Oximeter (WS20A), Pulse Oximeter (WS10A)
Pulse oximeter
FS10A,FS20A,FS10C,FS20C,FS10D,FS20D,FS10E,FS20E,HS10A,HS20A,
Pulse Oximeter FS10F and FS20F;Pulse Oximeter FS10I;Pulse Oximeter FS10K and FS20K;Pulse Oximeter FS10P;
Handheld Pulse Oximeter (model: HS20A)
Concord Fingertip Pulse Oximeter (model: 75079); Concord Handheld Pulse Oximeter (model: 75023)
Pulse Oximeter FS10B and FS20B
Handheld Pulse Oximeter-Rechargeable (model: 75023R)
Pulse oximeter(model:FS20P)
Concord Wrist Oximeter (model: 75044)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device