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Sign in to claim this brandNorth East Monitoring, Inc.
United States·US-MF-000019819
Last updated September 17, 2026
What North East Monitoring, Inc. makes
North East Monitoring, Inc. manufactures electrocardiographic devices for long-term ambulatory recording and cardiac arrhythmia monitoring, including Holter monitors and associated analysis software. Their portfolio includes hardware units like the DR200, DR181, and DR300, as well as specialized software for Holter analysis and sleep apnea monitoring. These devices are designed to continuously track heart rhythms and detect abnormalities over extended periods.
The company’s products are regulated under FDA 510(k) and UDI compliance in the US, with some devices classified as Class I or Class II (including Class IIa). They are also listed in the EU’s eudamed registry, indicating their presence in both domestic and international regulatory frameworks. The company is based in the United States.
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 North East Monitoring, Inc. manufacture?
North East Monitoring, Inc. specializes in electrocardiographic devices for long-term monitoring. Their primary products include ambulatory recording analysers, such as Holter monitors (e.g., DR200, DR181, DR300), and associated software for cardiac arrhythmia and sleep apnea analysis. These devices are designed to continuously record heart rhythms over extended periods, helping detect abnormalities like arrhythmias.
Where is North East Monitoring, Inc. based, and does it operate internationally?
North East Monitoring, Inc. is headquartered in the United States. While the company’s regulatory presence is primarily documented in the US (e.g., FDA 510(k) and UDI listings), its devices are also included in the EU’s eudamed registry, indicating participation in international markets. This suggests compliance with global regulatory standards, though the company itself is not a separate entity in the EU.
Which regulatory registries list North East Monitoring, Inc.’s devices?
North East Monitoring, Inc.’s devices are listed in three key regulatory databases: the FDA’s 510(k) and UDI registries (for US compliance) and the EU’s eudamed system. These listings reflect the company’s adherence to US and EU regulatory frameworks, though individual devices must undergo their own authorization processes (e.g., FDA clearance or EU CE marking) before commercialization.
How are North East Monitoring, Inc.’s devices classified under regulatory standards?
The company’s devices fall into different risk-based classifications under US regulations: most are Class I (low risk, e.g., general-purpose Holter monitors) or Class II (moderate risk, including Class IIa for specialized software like Holter analysis tools). Classification determines the regulatory scrutiny and pre-market requirements, such as 510(k) submissions for Class II devices, while Class I products may have fewer pre-market controls.
Why are some of North East Monitoring, Inc.’s devices listed in eudamed if the company is US-based?
The inclusion of North East Monitoring, Inc.’s devices in eudamed—the EU’s medical device registry—reflects their distribution or use within the European market, even if the company is US-headquartered. Manufacturers often list devices in eudamed if they are marketed in the EU, regardless of their headquarters location, to comply with EU regulatory transparency requirements. This does not imply the company itself is EU-based but confirms its devices meet EU regulatory standards for sale there.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 141, Parker Street, Maynard, United States
- Website
- www.nemon.com
- —
- —
- [email protected]
- Phone
- 9784613992
- PRRC Contact
- Sherry Steele
- EUDAMED SRN
- US-MF-000019819
- FDA FEI Number
- 1000513706
- DUNS Number
- —
Catalogue (32)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dr200 | DR200 5L | FDA UDI | Class II | Active |
| Dr181 | DR181 5L | FDA UDI | Class II | Active |
| Holter Analysis Software | Enhanced | FDA UDI | Class II | Active |
| Dr181 | DR181 7L | FDA UDI | Class II | Active |
| Dr181 | DR181 12L | FDA UDI | Class II | Active |
| Holter Analysis Software | Basic | FDA UDI | Class II | Active |
| Holter Analysis Software | Pro | FDA UDI | Class II | Active |
| Dr200 | DR200 3L | FDA UDI | Class II | Active |
| Dr300 | DR300 7L | FDA UDI | Class II | Active |
| Holter Analysis Software Apnea | Holter Analysis Software Apnea | FDA UDI | Class II | Active |
| Holter Analysis Software | Enhanced Plus | FDA UDI | Class II | Active |
| Dr200 | DR200 7L | FDA UDI | Class II | Active |
| Dr400 | DR400 | FDA UDI | Class II | Active |
| LX Event | LX Event Tool | FDA UDI | Class II | Active |
| Dr300 | DR300 5L | FDA UDI | Class II | Active |
| Dr200 | DR200 2L | FDA UDI | Class II | Active |
| Gateway | Gateway | FDA UDI | Class II | Active |
| Nemca133 | NEMCA133 | EUDAMED | Class I | Active |
| Dr300 Holter Monitor | K142424 | FDA 510(k) | Class II | Active |
| Sd360 Digital Recorder/Sd360 Holter Digital Recorder | K041901 | FDA 510(k) | Class II | Active |
| Dr180-R/Oxy | K983576 | FDA 510(k) | Class II | Active |
| Northeast Monitoring Dr180 | K960925 | FDA 510(k) | Class II | Active |
| Dr180-Ii | K001288 | FDA 510(k) | Class II | Active |
| Telaheart Digital Recorder | K061293 | FDA 510(k) | Class II | Active |
| Holter For Windows | K930564 | FDA 510(k) | Class II | Active |
| Auto Detect For Telaheart Dr200/E-A | K070014 | FDA 510(k) | Class II | Active |
| Dr180+oxy | K004007 | FDA 510(k) | Class II | Active |
| Dr400 | DR400 | EUDAMED | Class IIa | Active |
| Nemca134 | NEMCA134 | EUDAMED | Class I | Active |
| Dr200 | DR200 | EUDAMED | Class IIa | Active |
| Analysis Software | Holter LX Analysis | EUDAMED | Class IIa | Active |
| Nemel002 | NEMEL002 | EUDAMED | Class I | Active |
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