TeleRPM Gen2 Blood Glucose Monitoring System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- TeleRPM EUDAMED
- Device Name
- Blood Pressure Monitor EUDAMED
- Model / Reference
- TMB-2092-G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932825305838 EUDAMED
- Basic UDI-DI
- 69328253MDR10PR EUDAMED
- Direct Marketing DI
- 06932825305838 EUDAMED
- 510(k) Number
- K243060 FDA 510(k)
- FDA Product Code
- NBW FDA 510(k)
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1345 FDA 510(k)
- Regulation Number
- 862.1345 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
The TeleRPM Gen2 Blood Glucose Monitoring System is a Blood Glucose Monitoring Device (NBW) designed to quantitatively measure glucose concentration in fresh capillary whole blood using an amperometric detection method. It falls under the Clinical Chemistry category and is classified as a Class II device under FDA regulations (862.1345).
This system is intended for single-use in clinical settings, such as hospitals or laboratories, where precise glucose measurements are required. Supplied sterile and non-reusable, it adheres to FDA 510(k) clearance (K243060) and EU MDR compliance. No MRI safety information is specified, and storage conditions are not detailed in the available data.
Frequently asked questions
What types of clinical settings is the TeleRPM Gen2 Blood Glucose Monitoring System designed for, and how is it intended to be used there?
The TeleRPM Gen2 is specifically designed for single-use in clinical settings like hospitals or laboratories where accurate glucose measurements are critical. It measures glucose concentration in fresh capillary whole blood using an amperometric detection method, ensuring precise results for patient care in controlled environments.
Is the TeleRPM Gen2 Blood Glucose Monitoring System reusable, or is it meant for one-time use?
The TeleRPM Gen2 is explicitly intended for single-use only, as stated in its design and supply specifications. This ensures sterility and safety for clinical environments where precision and contamination control are essential.
What kind of regulatory approvals does the TeleRPM Gen2 Blood Glucose Monitoring System hold, and how does that affect its use?
The device holds FDA 510(k) clearance (K243060) and EU MDR compliance, confirming it meets regulatory standards for safety and performance. This approval allows it to be legally marketed and used in the U.S. and EU for its intended clinical purpose—quantitative glucose measurement in capillary whole blood.
How is the TeleRPM Gen2 Blood Glucose Monitoring System supplied, and what does that mean for handling and storage?
The system is supplied sterile, which means it is pre-sterilized to prevent contamination before use. While storage conditions aren’t detailed in the data, the single-use nature implies it should be stored in a clean, dry environment away from direct light or extreme temperatures to maintain its integrity until use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K243060 - TeleRPM Gen2 Blood Glucose Monitoring S..., PDF K243060 - accessdata.fda.gov, TeleRPM Gen2 Blood Glucose Monitoring System - BEUDAMED, TeleRPM Gen2 Blood Glucose Monitoring System — FDA K243060
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K243060 | Class II | Active |
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Manufacturer
- Manufacturer
- Guangdong Transtek Medical Electronics Co., Ltd
- FDA Applicant
- Guangdong Transtek Medical Electronics Co., Ltd.
Sources (2)
- FDA 510(k) K243060 24 fields · synced Oct 6, 2026
- EUDAMED 105738d5-0698-45ba-b204-19b2060efa17 61 fields · synced Aug 2, 2026