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Sign in to claim this brandWhat CAMNTECH LIMITED makes
Camntech Limited manufactures telemetric electrocardiographic ambulatory recorders, including wearable devices designed to continuously monitor heart rhythms over extended periods. These devices are intended for long-term ECG recording to assess cardiac function and detect arrhythmias in clinical or research settings.
The company’s products are classified as Class II medical devices under regulatory frameworks and are listed in the FDA’s Unique Device Identifier (UDI) database. The portfolio is regulated in the United States, where the manufacturer is based.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Camntech Limited manufacture?
Camntech Limited specializes in telemetric electrocardiographic ambulatory recorders, which are wearable devices designed to continuously monitor heart rhythms over extended periods. These devices are primarily used for long-term ECG recording to evaluate cardiac function and identify arrhythmias in clinical or research environments.
Where is Camntech Limited based, and where are its devices regulated?
Camntech Limited is based in the United States. Its devices are regulated in the U.S., where they fall under the jurisdiction of the FDA. The company’s products are classified as Class II medical devices, indicating a moderate level of risk that requires specific regulatory controls.
Are Camntech Limited’s devices listed in any regulatory registries?
Yes, Camntech Limited’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps ensure traceability and transparency of medical devices in the U.S. regulatory system, allowing for easier identification and monitoring of their compliance status.
How are Camntech Limited’s devices classified under regulatory frameworks?
Camntech Limited’s devices are classified as Class II medical devices. This classification is determined based on their intended use and associated risk level—specifically, their role in continuously monitoring heart rhythms for diagnostic purposes. Class II devices require special controls beyond general controls to mitigate risks, such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- camntech.com
- —
- —
- [email protected]
- Phone
- +1 830-755-8036
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 399114941
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Actiwave | Motion | FDA UDI | Class II | Unknown |
| Actiwave | 1E | FDA UDI | Class II | Unknown |
| Actiwave | 2E | FDA UDI | Class II | Unknown |
| Actiwave | Cardio | FDA UDI | Class II | Unknown |
| Actiwave | 2M | FDA UDI | Class II | Unknown |
| Actiheart | AH5 | FDA UDI | Class II | Active |
| Actiwave | 4E | FDA UDI | Class II | Unknown |
| Actiheart | AH4 | FDA UDI | Class II | Unknown |
| Actiheart | AH5 BT | FDA UDI | Class II | Active |
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