FDA Registration
Active
🇺🇸 United States
Telcare, LLC
Reg #: 3008514395
·
FEI: 3008514395
·
Expires 2026
Products
4
Proprietary Names
7
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- Telcare, LLC
- Registration Number
- 3008514395
- FEI Number
- 3008514395
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 600 West Ridge Road, Suite 200
- City
- Linwood
- State
- PA
- ZIP
- 19061
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110571
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 1217116
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2023-11-06 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2023-11-06 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2023-11-06 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2023-11-06 |
Proprietary Names
Telcare BGM
Telcare Cloud
Telcare
Philips Ambulatory Virtual Care Blood Glucose Monitoring System
Telcare Blood Glucose Monitoring System
BioTel Care BGM
BioTel Care Blood Glucose Monitoring System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device