FDA Registration
Active
🇺🇸 United States
Teladoc Health, Inc. - Lewisville
Reg #: 3021611414
·
FEI: 3021611414
·
Expires 2026
Products
10
Proprietary Names
24
Establishment Types
4
Classifications
10
Registration Details
- Registration Name
- Teladoc Health, Inc. - Lewisville
- Registration Number
- 3021611414
- FEI Number
- 3021611414
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1945 LAKEPOINTE DRIVE
- City
- Lewisville
- State
- TX
- ZIP
- 75057
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN170088
Owner / Operator
- Firm Name
- Teladoc Health, Inc.
- Operator Number
- 10047465
- Address
- 1945 Lakepointe Drive
- City
- Lewisville
- State
- TX
- Postal Code
- 75057
- Country
- US
- Correspondent
- Ileana Davis
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2026-01-14 |
| Scale, Stand-On, Patient | FRI | Class 1 | General Hospital | No | 2019-06-11 |
| Integrated Continuous Glucose Monitoring System, Factory Calibrated | QBJ | Class 2 | Clinical Chemistry | No | 2023-07-31 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2020-01-10 |
| Analyzer, Body Composition, Exempt | PUH | Class 2 | Cardiovascular | No | 2019-01-28 |
| Continuous Glucose Monitor Retrospective Data Analysis Software | PHV | Class 1 | Clinical Chemistry | No | 2025-12-09 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2026-01-14 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2026-01-14 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2025-12-11 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2014-09-11 |
Proprietary Names
Livongo App Retrospective CGM Data Analysis
Teladoc Health App Retrospective CGM Data Analysis
Livongo Blood Glucose Test Strips
Livongo Lancets
Livongo BGMS
Livongo Blood Glucose Monitoring System
Livongo Control Solution
Teladoc Health BGMS
Teladoc Health DMS
Livongo Strips
Livongo Blood Glucose Meter
Teladoc Health Control Solution
Teladoc Health Strips
Livongo Lancing Device
Livongo Meter
Teladoc Health Lancets
Teladoc Health Blood Glucose Meter
Livongo DMS
Teladoc Health Blood Glucose Test Strips
Livongo Data Management System
Teladoc Health Blood Glucose Monitoring System
Teladoc Health Data Management System
Teladoc Health Meter
Teladoc Health Lancing Device
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility