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Sign in to claim this brandMemtec Corporation
US
Last updated May 31, 2026
What Memtec Corporation makes
Memtec Corporation manufactures professional single-channel electrocardiographs and electrocardiographic long-term ambulatory recording analysers. Their product portfolio includes the Holter Monitor, the MobileECG System, and the MobileECG 2 BT.
These devices are classified as Class II medical devices and are based in the United States. The products are listed in the FDA 510(k) and FDA UDI databases.
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 Memtec Corporation manufacture?
Memtec Corporation specializes in electrocardiographic devices, specifically professional single-channel electrocardiographs and long-term ambulatory recording analysers. Their portfolio includes products like the Holter Monitor, which records heart activity over extended periods, and the MobileECG System and MobileECG 2 BT, designed for portable ECG monitoring. These devices help healthcare providers diagnose and monitor cardiac conditions.
Where is Memtec Corporation based?
Memtec Corporation is headquartered in the United States. While the exact location isn’t specified, the company’s regulatory listings and device classifications are tied to the US market, indicating its primary operational base is within the country.
Which regulatory registries list Memtec Corporation’s devices?
Memtec Corporation’s devices are included in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries track Class II medical devices that require regulatory clearance before commercial distribution in the US.
How are Memtec Corporation’s devices classified under medical device regulations?
Memtec Corporation’s devices fall under Class II classification in the US regulatory framework. This classification applies to devices that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as pre-market notification (510(k)) submissions.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 001048925
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Holter Monitor | Model 950-3CH | FDA UDI | Class II | Active |
| MobileECG System | MobileECG System | FDA UDI | N/A | Active |
| Model 700 | K944180 | FDA 510(k) | Class II | Active |
| Mobileecg System | K103427 | FDA 510(k) | Class II | Active |
| Model 950-12l Holter Recorder Without Analysis | K102723 | FDA 510(k) | Class II | Active |
| MobileECG 2 BT | K181658 | FDA 510(k) | Class II | Active |
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