FDA Registration
Active
🇨🇳 China
Automatic Upper Arm Blood Pressure Monitor (model: BA-821X, BA-822X, BA-823X, BA-826X, BA-818, BA-819, 1001e, MDS1001UE)
Reg #: 3017896172
·
FEI: 3017896172
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- DONGGUAN E-TEST TECHNOLOGY CO.,LTD
- Registration Number
- 3017896172
- FEI Number
- 3017896172
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 201, 301, Building 1, Changping Section No.1, Dongshen Road, Changping Town
- City
- Dongguan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K193627
Owner / Operator
- Firm Name
- DONGGUAN E-TEST TECHNOLOGY CO.,LTD
- Operator Number
- 10079208
- Address
- Room 201, 301, Building 1, Changping Section No.1, Dongshen Road, Changping Town
- City
- Dongguan
- State
- Guangdong
- Postal Code
- 523570
- Country
- CN
- Correspondent
- Victor Wan
US Agent
- Business Name
- SHARE INFO INC.
- Contact Name
- Clare Ho
- Address
- 3557 158th St Flushing, NY
- City
- Flushing
- State
- NY
- ZIP
- 11358
- Country
- US
- [email protected]
- Phone
- 929 4102964
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2020-11-24 |
Proprietary Names
Automatic Upper Arm Blood Pressure Monitor (model: BA-821X, BA-822X, BA-823X, BA-826X, BA-818, BA-819, 1001e, MDS1001UE)
Automatic Upper Arm Blood Pressure Monitor (model :BA-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813
Automatic Upper Arm Blood Pressure Monitor (model: BA-832X)
Automatic Upper Arm Blood Pressure Monitor (model: MDS4001, MDS4001LA, MDS4001LAT, MDS4001PLUS, MDS5001)
Automatic Upper Arm Blood Pressure Monitor (model: MDS1001, MDS1001U, MDS1001UT, MDS1001CS)
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device