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Sign in to claim this brandTELCARE, LLC
US
Last updated May 30, 2026
What TELCARE, LLC makes
Telcare, LLC manufactures home-use in vitro diagnostic glucose monitoring systems, including the BioTel Care Blood Glucose Monitoring System, test strips, and control solutions. The company also produces the Telserve Data Management System, which provides self-care monitoring and reporting software.
The company is based in the United States, and its product portfolio consists of Class I and Class II medical devices. These devices are listed within the FDA UDI database.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
Where is Telcare, LLC based and what types of products do they manufacture?
Telcare, LLC is a United States-based company that specializes in the production of home-use in vitro diagnostic glucose monitoring systems. Their product portfolio includes the BioTel Care Blood Glucose Monitoring System, test strips, and control solutions, as well as the Telserve Data Management System, which is designed for self-care monitoring and reporting software.
How are the medical devices produced by Telcare, LLC classified?
The medical devices manufactured by Telcare, LLC are classified as either Class I or Class II devices. This classification system is used to categorize medical devices based on the level of regulatory control necessary to ensure their safety and effectiveness.
Where can I find information regarding the devices manufactured by Telcare, LLC?
Information regarding the devices manufactured by Telcare, LLC, such as the BioTel Care BGM 4 and the Telserve Data Management System, is available through the FDA UDI database. This registry serves as a public source for identifying medical devices and their specific attributes.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- telcare.com
- —
- —
- [email protected]
- Phone
- 877-777-4710
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 116979417
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BioTel Care BGM 4 | TM0009 | FDA UDI | Class II | Active |
| Telserve® Data Management System | DMS | FDA UDI | Class I | Active |
| BioTel Care® Blood Glucose Monitoring System | BGM | FDA UDI | Class II | Active |
| BioTel Care® Double Control Solution | CS | FDA UDI | Class I | Active |
| BioTel Care® Test Strips | TS | FDA UDI | Class II | Active |
| Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home Use, Telserve-Professional Use | K110571 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Telcare, LLC has one FDA recall record initiated on January 30, 2025, involving its Philips Connected Blood Glucose Meter Monitoring System (BGM 4 brand). The recall is open and also classified, with the reason stated as customer complaints regarding battery expansion or swelling, identified through post-market surveillance data.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 30, 2025 | Z-1270-2025 | — | open, classified | Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monitoring System.. The issue was identified by post market surveillance data (customer complaints) - events of battery expansion/swelling and associated symptoms, e.g., leading to the device's removable back cover (battery port) to separate. If there is a loss of primary function of the device due to the described device defect, an immediate health consequence that may result is prolonged hypoglycemia or hyperglycemia due to delay in treatment, as the blood glucose measurement is not available to guide treatment. In a worst-case situation, there is potential for battery swelling to result in explosion of the battery and/ or device. Exposure to explosion, and subsequently projectiles from the explosion, may result in several immediate health consequences, including concussion, headache, dizziness, eye irritation, blurred vision, eye injury, and vision impairment. |