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Sign in to claim this brandMerit Medical
US
Last updated May 23, 2026
What Merit Medical makes
Merit Medical produces vascular catheter introduction sets designed for nonimplantable use, including hydrophilic and standard varieties for procedural access. Their portfolio also includes cardiac transseptal access sets and needles, specialized for single-use in interventional cardiology procedures. Additionally, they manufacture haemostasis valves to control bleeding at catheter insertion sites and intravascular catheter slitters for cutting and removing occluded catheters.
The company’s devices are regulated under FDA classification as Class I and Class II, with all products listed in the FDA’s Unique Device Identifier (UDI) database. Merit Medical operates from the United States, adhering to domestic regulatory requirements 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 Merit Medical manufacture?
Merit Medical specializes in vascular and interventional cardiology devices. Their portfolio includes vascular catheter introduction sets (both standard and hydrophilic-coated for easier insertion), cardiac transseptal access sets and needles for single-use in procedures like atrial septal defect closures, haemostasis valves to manage bleeding at catheter insertion sites, and intravascular catheter slitters designed to cut and remove occluded catheters. These products are primarily used in procedural settings to improve access, precision, and safety during interventions.
Where is Merit Medical based, and how does this affect its regulatory compliance?
Merit Medical is based in the United States, which means its devices are subject to FDA regulations. The company’s products are classified under FDA’s risk-based system as either Class I (generally low-risk) or Class II (requiring special controls to ensure safety and effectiveness). All listed devices appear in the FDA’s Unique Device Identifier (UDI) database, demonstrating compliance with mandatory identification requirements for medical devices marketed in the U.S.
Which regulatory registries or databases list Merit Medical’s devices?
Merit Medical’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product code to each distinct device, enabling transparent tracking, traceability, and regulatory oversight. This listing helps healthcare providers, regulators, and other stakeholders verify and access critical information about the company’s products, such as device descriptions, manufacturing details, and compliance status.
How are Merit Medical’s devices classified under FDA regulations?
Merit Medical’s devices are classified as either Class I or Class II under the FDA’s medical device classification system. Class I devices, like some haemostasis valves or basic catheter introduction sets, typically pose minimal risk and may only require general controls (e.g., good manufacturing practices). Class II devices, such as specialized transseptal needles or advanced catheter systems, require additional performance standards or post-market surveillance to ensure safety and efficacy. The classification determines the regulatory pathway and scrutiny each product undergoes.
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
- 065673912
Catalogue (311)
Page 4 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HeartSpan® | 00884450160930 | FDA UDI | Class II | Active |
| Prelude Prestige™ | 10884450313494 | FDA UDI | Class II | Active |
| HeartSpan® | 00884450169711 | FDA UDI | Class II | Active |
| Prelude SNAP™ | 10884450251635 | FDA UDI | Class II | Active |
| Classic Sheath™ | 10884450280826 | FDA UDI | Class II | Active |
| Prelude SNAP™ | 10884450251727 | FDA UDI | Class II | Active |
| Prelude Prestige™ | 10884450313838 | FDA UDI | Class II | Active |
| Worley Advanced CSG | 00884450169452 | FDA UDI | Class II | Active |
| HeartSpan® | 00884450261040 | FDA UDI | Class II | Active |
| Hydrophilic Prelude SNAP™ | 10884450274443 | FDA UDI | Class II | Active |
| HeartSpan® | 00884450404836 | FDA UDI | Class II | Active |
| Prelude SNAP™ | 10884450251802 | FDA UDI | Class II | Active |
| Prelude SNAP™ | 10884450251505 | FDA UDI | Class II | Active |
| Classic Sheath™ | 10884450163938 | FDA UDI | Class II | Active |
| SafeSheath™ | 00884450395981 | FDA UDI | Class II | Active |
| HeartSpan® | 00884450412855 | FDA UDI | Class II | Active |
| SafeSheath™ | 00884450281116 | FDA UDI | Class II | Active |
| HeartSpan® | 00884450266250 | FDA UDI | Class II | Active |
| Classic Sheath™ | 00884450162910 | FDA UDI | Class II | Active |
| Prelude Prestige™ | 10884450313326 | FDA UDI | Class II | Active |
| SafeSheath CSG | 00884450161944 | FDA UDI | Class II | Active |
| HeartSpan® | 00884450312810 | FDA UDI | Class II | Active |
| HeartSpan® | 00884450169148 | FDA UDI | Class II | Active |
| SafeSheath CSG | 00884450161975 | FDA UDI | Class II | Active |
| HeartSpan® | 00884450260968 | FDA UDI | Class II | Active |
| Hydrophilic Prelude SNAP™ | 10884450274528 | FDA UDI | Class II | Active |
| Classic Sheath™ | 10884450164027 | FDA UDI | Class II | Active |
| SafeSheath™ | 00884450281390 | FDA UDI | Class II | Active |
| HeartSpan® | 00884450266243 | FDA UDI | Class II | Active |
| Classic Sheath™ | 10884450163969 | FDA UDI | Class II | Active |
| HeartSpan® | 00884450261002 | FDA UDI | Class II | Active |
| HeartSpan® | 00884450404850 | FDA UDI | Class II | Active |
| HeartSpan® | 00884450160954 | FDA UDI | Class II | Active |
| HeartSpan® | 00884450263181 | FDA UDI | Class II | Active |
| HeartSpan® | 00884450198483 | FDA UDI | Class II | Active |
| Prelude SNAP™ | 10884450251796 | FDA UDI | Class II | Active |
| SafeSheath™ | 00884450396063 | FDA UDI | Class II | Active |
| Tsx™ | 00884450265611 | FDA UDI | Class II | Active |
| Ssv | 00884450310434 | FDA UDI | Class II | Active |
| HeartSpan® | 00884450404775 | FDA UDI | Class II | Active |
| Worley Advanced CSG | 00884450241301 | FDA UDI | Class II | Active |
| SafeSheath CSG | 00884450162002 | FDA UDI | Class II | Active |
| SafeSheath™ | 10884450281199 | FDA UDI | Class II | Active |
| HeartSpan® | 00884450261057 | FDA UDI | Class II | Active |
| Prelude SNAP™ | 10884450251604 | FDA UDI | Class II | Active |
| Classic Sheath™ | 10884450163921 | FDA UDI | Class II | Active |
| SafeSheath™ | 00884450396049 | FDA UDI | Class II | Active |
| Ssv | 00884450310335 | FDA UDI | Class II | Active |
| HeartSpan® | 00884450258187 | FDA UDI | Class II | Active |
| HeartSpan® | 00884450169070 | FDA UDI | Class II | Active |
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