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Sign in to claim this brandHEMEDEX, INC
US
Last updated May 25, 2026
What HEMEDEX, INC makes
HemeDex, Inc. manufactures intracranial pressure monitoring devices, including intracerebral catheters, cranial-fixation kits, and specialized drill bits for catheter placement. Their product line also covers perfusion probes and monitoring systems designed to measure and manage cerebral blood flow in clinical settings. Accessory kits and bolt systems for securing catheters are also part of their offerings.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States, where its products are subject to FDA oversight and compliance requirements.
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 HemeDex, Inc. manufacture?
HemeDex, Inc. specializes in devices related to intracranial pressure monitoring and cerebral perfusion management. Their product line includes intracerebral catheters, cranial-fixation kits for securing catheters, specialized drill bits for catheter placement, perfusion probes, and patient monitoring systems for intracranial pressure. These devices are designed to help clinicians measure and manage cerebral blood flow and pressure in critical care settings.
Where is HemeDex, Inc. based, and how does that affect its devices?
HemeDex, Inc. is based in the United States, which means its devices are subject to FDA regulations and compliance requirements. Being a U.S.-based manufacturer, their products must adhere to FDA standards for safety, performance, and labeling before they can be marketed. This oversight ensures that devices like their intracranial pressure monitoring systems and related accessories meet rigorous regulatory criteria.
Which regulatory registries or databases list HemeDex, Inc.’s devices?
HemeDex, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in regulatory compliance and recall management. Listing in this database is a requirement for Class II devices, which includes HemeDex’s products.
How are HemeDex, Inc.’s devices classified under FDA regulations?
HemeDex, Inc.’s devices are classified as Class II under FDA regulations. Class II devices are those that pose moderate risk and require special controls to ensure their safety and effectiveness. These controls may include performance standards, post-market surveillance, or labeling requirements. Classification helps determine the regulatory pathway and oversight needed for each device type.
What is the purpose of the drill bits and cranial-fixation kits produced by HemeDex, Inc.?
The drill bits and cranial-fixation kits from HemeDex, Inc. are designed to assist in the precise placement and secure fixation of intracerebral catheters. The drill bits create accurate entry points for catheter insertion, while the cranial-fixation kits ensure the catheter remains properly positioned and stable during monitoring. These components are critical for maintaining the integrity of intracranial pressure measurements and reducing complications in clinical use.
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
- 128045676
Catalogue (15)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| QFlow 500 Perfusion Probe | NA | FDA UDI | Class II | Active |
| QFlow 500 2.7mm Drill Bit Kit | NA | FDA UDI | Class II | Active |
| QFlow 500 Titanium Bolt-Quad Lumen Bolt Kit | NA | FDA UDI | Class II | Active |
| QFlow 500 Quad Lumen Cranial Bolt Large-Lumen Introducer | NA | FDA UDI | Class II | Active |
| Bowman Perfusion Monitor, 120V | Model 500 | FDA UDI | Class II | Active |
| Bowman Perfusion Monitor, 240V | Model 500 | FDA UDI | Class II | Active |
| QFlow 500 Bolt Accessory Kit | NA | FDA UDI | Class II | Active |
| QFlow 500 Titanium Bolt-Dual Lumen | NA | FDA UDI | Class II | Active |
| QFlow 500 Male-Female Luer Coupler | NA | FDA UDI | Class II | Active |
| QFlow 500 Titanium Bolt-Single Lumen Bolt Kit | NA | FDA UDI | Class II | Active |
| QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit with Introducer | NA | FDA UDI | Class II | Active |
| QFlow 500 5.3mm Drill Bit Kit | NA | FDA UDI | Class II | Active |
| QFlow 500 Probe Dura Piercer and Introducer Kit | NA | FDA UDI | Class II | Active |
| QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit | NA | FDA UDI | Class II | Active |
| QFlow 500 Titanium Bolt-Single Lumen | NA | FDA UDI | Class II | Active |
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