FDA Registration
Active
🇺🇸 United States
ANRIWELL
Reg #: 3043513123
·
FEI: 3043513123
·
Expires 2026
Products
5
Proprietary Names
9
Establishment Types
2
Classifications
5
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Registration Details
- Registration Name
- ANRIWELL
- Registration Number
- 3043513123
- FEI Number
- 3043513123
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2062 Business Center Dr Ste 125
- City
- Irvine
- State
- CA
- ZIP
- 92612
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232989
Owner / Operator
- Firm Name
- Anriwell
- Operator Number
- 10095154
- Address
- 2062 BUSINESS CENTER DRIVE, STE 125
- City
- Irvine
- State
- CA
- Postal Code
- 92604
- Country
- US
- Correspondent
- YINING CHEN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2026-01-29 |
| Oximeter, Wellness | PGJ | Class 2 | Cardiovascular | No | 2026-04-09 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2026-01-29 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2026-03-19 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2026-03-19 |
Proprietary Names
AW-401
Anriwell Breeze
Anriwell Breeze (OTC)
Anriwell Tempie
AW-201
Anriwell Gluco
AW-501
AW-301
Anriwell Pressia
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility