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Sign in to claim this brandMeridian Medical Systems, LLC
US
Last updated May 27, 2026
What Meridian Medical Systems, LLC makes
Meridian Medical Systems, LLC produces flat panel x-ray detector integration units, designed to interface with radiographic imaging systems for enhanced digital capture and processing of x-ray images. The devices are branded as Monarch and are used in medical imaging workflows to improve image quality and efficiency in diagnostic settings.
The company’s products fall under FDA Class II regulatory classification and are listed via 510(k) clearance and the FDA’s Unique Device Identifier (UDI) system. These devices are intended for use within the United States regulatory framework.
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 Meridian Medical Systems, LLC manufacture?
Meridian Medical Systems, LLC specializes in flat panel x-ray detector integration units, specifically designed to connect with radiographic imaging systems. These devices, branded as *Monarch*, enhance digital x-ray image capture and processing, improving diagnostic imaging quality and workflow efficiency in clinical settings.
Where is Meridian Medical Systems, LLC based, and how does that affect its regulatory compliance?
Meridian Medical Systems, LLC is based in the United States, which means its devices are regulated under the FDA’s framework. Since the company’s products fall under Class II classification, they must comply with FDA requirements such as 510(k) clearance and Unique Device Identifier (UDI) registration to ensure safety, performance, and traceability in the U.S. market.
Which regulatory registries or databases list Meridian Medical Systems, LLC’s devices?
Meridian Medical Systems, LLC’s devices are listed in the FDA’s 510(k) database (for premarket clearance) and the FDA’s Unique Device Identifier (UDI) system, which tracks device identification and compliance. These registries ensure transparency and verification of the company’s products within the U.S. regulatory environment.
How are Meridian Medical Systems, LLC’s devices classified by regulatory authorities?
Meridian Medical Systems, LLC’s devices are classified as FDA Class II, meaning they pose moderate risk and require specific regulatory controls. This classification includes mandatory 510(k) clearance (demonstrating substantial equivalence to a predicate device) and compliance with UDI requirements to maintain authorization for market distribution in the U.S.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- meridianmed.net
- —
- —
- [email protected]
- Phone
- 844-628-5638
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 078759601
Catalogue (24)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Monarch | RT 303 | FDA UDI | Class II | Active |
| Monarch | RT 203 | FDA UDI | Class II | Active |
| Monarch | RT 302 | FDA UDI | Class II | Active |
| Monarch | RT 308 | FDA UDI | Class II | Active |
| Monarch | RT 310 | FDA UDI | Class II | Active |
| Monarch | RT 307 | FDA UDI | Class II | Active |
| Monarch | RT 306 | FDA UDI | Class II | Active |
| Monarch | RT 304 | FDA UDI | Class II | Active |
| Monarch | RT 301 | FDA UDI | Class II | Active |
| Paragon 2 | RT312 | FDA UDI | Class II | Unknown |
| Monarch | RT 305 | FDA UDI | Class II | Active |
| Monarch | RT 201 | FDA UDI | Class II | Active |
| Monarch | RT 202 | FDA UDI | Class II | Active |
| Monarch | RT 311 | FDA UDI | Class II | Active |
| Monarch | RT 309 | FDA UDI | Class II | Active |
| Monarch | RT 204 | FDA UDI | Class II | Active |
| Universal Digital Interface Wireless - Udi 1417w | K111305 | FDA 510(k) | Class II | Active |
| Disposable, Preformed Face Mask | K944157 | FDA 510(k) | Class I | Active |
| Paragon 2 | K162687 | FDA 510(k) | Class II | Active |
| Universal Digital Interface 2W, UDI 2W | K143232 | FDA 510(k) | Class II | Active |
| Universal Digital Interface (udi) 1717 | K103599 | FDA 510(k) | Class II | Active |
| Universal Digital Interface 2, Udi 2 | K140251 | FDA 510(k) | Class II | Active |
| Meridian Medical Systems Mapleson D And Modified Jackson Reese Circuits | K945984 | FDA 510(k) | Class I | Active |
| Universal Digital Interface (udi) 1717 | K112527 | FDA 510(k) | Class II | Active |
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