FDA Registration
Active
🇺🇸 United States
MIO LABS INC.
Reg #: 3022418645
·
FEI: 3022418645
·
Expires 2026
Products
3
Proprietary Names
3
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- MIO LABS INC.
- Registration Number
- 3022418645
- FEI Number
- 3022418645
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- KCH, 575 Lexington Ave 14F New York
- City
- Franklin D Roosevelt
- State
- NY
- ZIP
- 10022
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223722
Owner / Operator
- Firm Name
- Mio Labs Inc.
- Operator Number
- 10084983
- Address
- 4500 Great America Pkwy Suite 1023
- City
- Santa Clara
- State
- CA
- Postal Code
- 95054
- Country
- US
- Correspondent
- Jialong Fan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2023-07-24 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2024-08-26 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2024-08-26 |
Proprietary Names
MIO Blood Glucose Monitoring System, model: TeleBGM2282-G
TeleRPM Blood Glucose Monitoring System, Meter model: TMB-2282-G, Test strips model: TTS01
Pylo Blood Glucose Monitoring System, Meter model: GL1-LTE, Test strips model:GL1-STP-50
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device