Is this your brand? Sign in to claim ownership.
Sign in to claim this brandSILEX GLOBAL LLC
US
Last updated May 30, 2026
What SILEX GLOBAL LLC makes
The company manufactures blood pressure measurement devices, including aneroid manual sphygmomanometers and portable automatic-inflation electronic sphygmomanometers designed for arm or wrist use. It also produces mechanical external stethoscopes for auscultation, as well as digital thermometers for non-invasive temperature monitoring, including infrared models for ear and skin use and intermittent electronic models for patient readings.
The portfolio includes devices classified as Class I and Class II under regulatory frameworks, with several products listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable domestic and international regulatory standards for medical devices.
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 Silex Global LLC manufacture?
Silex Global LLC specializes in blood pressure measurement devices, such as aneroid manual sphygmomanometers (manual cuff-based devices) and portable automatic-inflation electronic sphygmomanometers for arm or wrist use. The company also produces mechanical external stethoscopes for auscultation and digital thermometers, including infrared models for ear/skin and intermittent electronic models for patient temperature monitoring. These devices are designed for clinical and home use.
Where is Silex Global LLC based, and does its location affect its device regulations?
Silex Global LLC is based in the United States. Since it operates domestically, its devices are subject to U.S. regulatory requirements, including classification under FDA guidelines. The company’s products listed in the FDA’s Unique Device Identifier (UDI) database reflect compliance with U.S. medical device regulations, though individual devices must still meet specific authorization criteria for market clearance.
Which regulatory registries or databases list Silex Global LLC’s devices?
Several of Silex Global LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices in the U.S. market, ensuring transparency and traceability. While this listing indicates regulatory engagement, it does not imply device authorization—only that the devices are formally registered under FDA requirements.
How are Silex Global LLC’s devices classified under regulatory frameworks?
Silex Global LLC’s devices fall into two primary regulatory classes: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and may need special controls to ensure safety and effectiveness. Classification depends on factors like the device’s intended use, potential health impact, and design complexity, as determined by regulatory bodies like the FDA.
What does it mean for a Silex Global LLC device to be listed in the FDA’s UDI database?
Listing in the FDA’s Unique Device Identifier (UDI) database means the device has been assigned a standardized identifier to improve tracking, traceability, and transparency in the U.S. medical device market. This does not mean the device is automatically authorized for sale—it simply confirms the manufacturer has registered the device with the FDA as required. The UDI helps healthcare providers, regulators, and patients identify and verify devices more easily.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- [email protected]
- Phone
- 1-307-212-8504
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 081135914
Catalogue (33)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Paramed | MAX02 | FDA UDI | Class II | Active |
| Paramed | Manual Blood Pressure cuff (Pink Color). Basic Model | FDA UDI | Class II | Active |
| Paramed | Manual Blood Pressure cuff (Black Color). Basic Model | FDA UDI | Class II | Active |
| Paramed | Digital Blood Pressure Monitor (Upper-arm) B15 | FDA UDI | Class II | Active |
| paramed | Infrared ear/forehead thermometer PG-IRT1603 | FDA UDI | Class II | Active |
| Paramed | MAX02 | FDA UDI | Class II | Active |
| Paramed | Digital Blood Pressure Monitor (Upper-arm) B22 | FDA UDI | Class II | Active |
| Paramed | B51 | FDA UDI | Class II | Active |
| Paramed | MAX0201 | FDA UDI | Class II | Active |
| Paramed | CM-BPM-S | FDA UDI | Class II | Active |
| Paramed | CM-BPM-S | FDA UDI | Class II | Active |
| Paramed | Manual Blood Pressure cuff (Black Color). Comfort Model | FDA UDI | Class II | Active |
| Paramed | MAX02 | FDA UDI | Class II | Active |
| Paramed | Digital Blood Pressure Monitor (Upper-arm) B22S | FDA UDI | Class II | Active |
| Paramed | MAX0201 | FDA UDI | Class II | Active |
| Paramed | Wrist Blood Pressure monitor PG-800A12 | FDA UDI | Class II | Active |
| Paramed | CM-BPM | FDA UDI | Class II | Active |
| Paramed | Digital Blood Pressure Monitor (Upper-arm) B22 | FDA UDI | Class II | Active |
| Paramed | CM-4136 | FDA UDI | Class I | Active |
| Paramed | CM-BPM | FDA UDI | Class II | Active |
| Paramed | RH3009 | FDA UDI | Class I | Active |
| Paramed | Thermometer DT001 | FDA UDI | Class II | Active |
| Paramed | CM-BPM-S | FDA UDI | Class II | Active |
| paramed | Infrared ear/forehead thermometer YK-IRT1 | FDA UDI | Class II | Active |
| Paramed | Manual Blood Pressure cuff (Blue Color). Comfort Model | FDA UDI | Class II | Active |
| Paramed | MAX0201 | FDA UDI | Class II | Active |
| Paramed | CM-BPM | FDA UDI | Class II | Active |
| Paramed | PG-800A11 | FDA UDI | Class II | Active |
| Paramed | Manual Blood Pressure cuff (Blue Color). PRO Model | FDA UDI | Class II | Active |
| Paramed | Manual Blood Pressure cuff (Pink Color). Comfort Model | FDA UDI | Class II | Active |
| Paramed | RH3012 | FDA UDI | Class I | Active |
| paramed | Wrist Blood Pressure monitor PG-800A37 | FDA UDI | Class II | Active |
| Paramed | Manual Blood Pressure cuff (Blue Color). Basic Model | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.