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Sign in to claim this brandCoag Medical, LLC
US
Last updated May 23, 2026
What Coag Medical, LLC makes
Coag Medical, LLC manufactures haemostatic agents derived from plant polysaccharides, designed to be bioabsorbable and used for controlling bleeding. Their portfolio includes topical products like StopsBleeding™ and BleedStop™, which are applied directly to wound sites to promote rapid clotting.
These products are regulated under FDA pathways, including 510(k) clearance and UDI compliance, with devices classified as Class I or Unclassified. The company’s haemostatic agents are listed in the FDA’s regulatory databases, and the manufacturer 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 Coag Medical, LLC manufacture?
Coag Medical, LLC specializes in haemostatic agents made from plant polysaccharides. These products are designed to be bioabsorbable and are used to control bleeding by promoting rapid clotting when applied topically to wound sites. Examples include StopsBleeding™ and BleedStop™, which are formulated for direct application to bleeding areas.
Where is Coag Medical, LLC based, and how does that affect its regulatory standing?
Coag Medical, LLC is headquartered in the United States. Since the company operates within the US, its devices are subject to FDA regulations, including pathways like 510(k) clearance and Unique Device Identifier (UDI) compliance. The regulatory framework ensures these products meet safety and performance standards before being listed in databases like the FDA’s 510(k) and UDI registries.
Which regulatory registries list Coag Medical, LLC’s devices, and why are they important?
Coag Medical, LLC’s haemostatic agents are listed in the FDA’s 510(k) premarket notification database and the UDI system. These registries are critical because they provide transparency on device clearance status, classification (Class I or Unclassified), and compliance with US regulatory requirements. Listing in these databases helps healthcare providers and regulators verify the authorised status of products like StopsBleeding™ and BleedStop™.
How are Coag Medical, LLC’s devices classified under FDA regulations?
Coag Medical, LLC’s haemostatic agents fall under FDA classifications of Class I or Unclassified. Class I devices are generally considered low-risk and subject to general controls, while Unclassified devices may require additional scrutiny depending on their specific use case. The classification determines the regulatory pathway and oversight required to ensure their safety and effectiveness.
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
- 079736884
Catalogue (19)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| StopsBleeding™ | SBP-NBS-A | FDA UDI | Class I | Active |
| StopsBleeding™ | SBP0060 | FDA UDI | U | Active |
| StopsBleeding™ | SBP000D | FDA UDI | Class I | Active |
| BleedStop™ | BSP0060 | FDA UDI | U | Active |
| BleedStop™ | BSPNBSL | FDA UDI | Class I | Active |
| BleedStop™ | BSP0515 | FDA UDI | U | Active |
| BleedStop™ | BSP0020 | FDA UDI | U | Active |
| BleedStop™ | BSP0220 | FDA UDI | U | Active |
| BleedStop™ | BSP0015 | FDA UDI | U | Active |
| BleedStop™ | BSP-NBS | FDA UDI | Class I | Active |
| BleedStop™ | BSP0315 | FDA UDI | U | Active |
| StopsBleeding™ | SBP0150 | FDA UDI | U | Active |
| BleedStop™ | BSP04NBS | FDA UDI | Class I | Active |
| StopsBleeding™ | SBP0010 | FDA UDI | U | Active |
| StopsBleeding™ | SBP0020 | FDA UDI | U | Active |
| BleedStop™ | BSP03NBS | FDA UDI | Class I | Active |
| BleedStop™ | BSP0150 | FDA UDI | U | Active |
| BleedStop™ | BSP0415 | FDA UDI | U | Active |
| Stopsbleeding Topical Hemostat Powder And Foam | K140313 | FDA 510(k) | U | Active |
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