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Sign in to claim this brandCOASTAL LIFE TECHNOLOGIES, INC.
US
Last updated May 30, 2026
What COASTAL LIFE TECHNOLOGIES, INC. makes
Coastal Life Technologies, Inc. manufactures components and systems for surgical plume evacuation, including single-use tubes, filters, and evacuation devices designed to manage smoke and particulate during procedures. Their portfolio also includes urogenital surgical laser beam guides and ERCP catheters, as well as laparoscopic plume filters and suction system filters for plume particulates. These products are intended for use in minimally invasive and laparoscopic surgeries to improve operating room air quality and reduce exposure to surgical smoke.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Their products are regulated under U.S. medical device laws, ensuring compliance with safety and performance standards for surgical and procedural applications. 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 Coastal Life Technologies, Inc. manufacture?
Coastal Life Technologies, Inc. specializes in devices related to surgical plume management and urogenital surgical procedures. Their portfolio includes single-use components like surgical plume evacuation system tubes, filters (for plume particulates and laparoscopic use), suction system filters, and ERCP catheters. They also produce urogenital surgical laser system beam guides. These products are designed to improve air quality and reduce exposure to surgical smoke during minimally invasive and laparoscopic surgeries.
Where is Coastal Life Technologies, Inc. based, and how does that affect its regulatory standing?
Coastal Life Technologies, Inc. is based in the United States, which means its devices are subject to U.S. medical device regulations. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, indicating compliance with U.S. requirements for traceability and identification. However, individual devices must undergo their own regulatory processes to demonstrate safety and performance before they can be authorized for use.
Which regulatory registries or databases list devices manufactured by Coastal Life Technologies, Inc.?
Devices from Coastal Life Technologies, Inc. are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each device has a standardized identifier for tracking and compliance purposes. While the UDI database is a key resource for identifying their products, specific regulatory clearance or approval is determined on a per-device basis, not at the company level.
How are devices from Coastal Life Technologies, Inc. classified under FDA regulations?
Coastal Life Technologies, Inc.’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway each device must follow to demonstrate compliance with FDA requirements before authorization.
What is the primary purpose of the devices manufactured by Coastal Life Technologies, Inc.?
The primary purpose of Coastal Life Technologies, Inc.’s devices is to manage surgical plume—such as smoke and particulate matter—generated during procedures like minimally invasive surgeries, laparoscopy, and urogenital laser treatments. Their products, including evacuation systems, filters, and beam guides, are designed to improve operating room air quality, reduce exposure risks to healthcare personnel, and enhance procedural safety by mitigating the hazards associated with surgical smoke.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- surgimedics.com
- —
- —
- [email protected]
- Phone
- 1 (800) 645-7418
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 809254670
Catalogue (74)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Surgimedics® | 902034 | FDA UDI | Class I | Active |
| Surgimedics® | 901409 | FDA UDI | Class II | Active |
| Surgimedics® | 901300 | FDA UDI | Class II | Active |
| Surgimedics® | 901201 | FDA UDI | Class II | Active |
| Surgimedics® | 902037 | FDA UDI | Class I | Active |
| Surgimedics® | 901417 | FDA UDI | Class II | Active |
| Surgimedics® | 901205 | FDA UDI | Class II | Active |
| Surgimedics® | 9S-4065 | FDA UDI | Class II | Active |
| Surgimedics® | 906760 | FDA UDI | Class II | Active |
| Surgimedics® | 905015 | FDA UDI | Class I | Active |
| Surgimedics® | 9S-6060 | FDA UDI | Class II | Active |
| Surgimedics® | 9S-5221 | FDA UDI | Class II | Active |
| Surgimedics® | 905080 | FDA UDI | Class I | Active |
| Surgimedics® | 905060 | FDA UDI | Class I | Active |
| Surgimedics® | 905019 | FDA UDI | Class I | Active |
| Surgimedics® | 901407 | FDA UDI | Class II | Active |
| Surgimedics® | 9S-6062 | FDA UDI | Class II | Active |
| Surgimedics® | 905011 | FDA UDI | Class I | Active |
| Surgimedics® | 905025 | FDA UDI | Class I | Active |
| Surgimedics® | 905053 | FDA UDI | Class I | Active |
| Surgimedics® | 901412 | FDA UDI | Class II | Active |
| Surgimedics® | 901054 | FDA UDI | Class I | Active |
| Surgimedics® | 905022 | FDA UDI | Class I | Active |
| Surgimedics® | 901202 | FDA UDI | Class II | Active |
| Surgimedics® | 901301 | FDA UDI | Class II | Active |
| Surgimedics® | 901410 | FDA UDI | Class II | Active |
| Surgimedics® | 901025 | FDA UDI | Class I | Active |
| Surgimedics® | 901206 | FDA UDI | Class II | Active |
| Surgimedics® | 905046 | FDA UDI | Class I | Active |
| Surgimedics® | 9S-5601 | FDA UDI | Class II | Active |
| Surgimedics® | 905017 | FDA UDI | Class I | Active |
| Surgimedics® | 9S-6075 | FDA UDI | Class II | Active |
| Surgimedics® | 906151 | FDA UDI | Class II | Active |
| Surgimedics® | 905055 | FDA UDI | Class I | Active |
| Surgimedics® | 901418 | FDA UDI | Class II | Active |
| Surgimedics® | 906500 | FDA UDI | Class II | Active |
| Surgimedics® | 905021 | FDA UDI | Class I | Active |
| Surgimedics® | 901302 | FDA UDI | Class I | Active |
| Surgimedics® | 901425 | FDA UDI | Class II | Active |
| Surgimedics® | 901007 | FDA UDI | Class I | Active |
| Surgimedics® | 901415 | FDA UDI | Class II | Active |
| Surgimedics® | 907001 | FDA UDI | Class I | Active |
| Surgimedics® | 905054 | FDA UDI | Class I | Active |
| Surgimedics® | 905066 | FDA UDI | Class I | Active |
| Surgimedics® | 905045 | FDA UDI | Class I | Active |
| Surgimedics® | 901051 | FDA UDI | Class I | Active |
| Surgimedics® | 901405 | FDA UDI | Class II | Active |
| Surgimedics® | 901002 | FDA UDI | Class I | Active |
| Surgimedics® | 9S-6061 | FDA UDI | Class II | Active |
| Surgimedics® | 905012 | FDA UDI | Class I | Active |
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