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Sign in to claim this brandBCM Co., Ltd.
US
Last updated May 25, 2026
What BCM Co., Ltd. makes
BCM Co., Ltd. manufactures polymer-metal esophageal stents designed for treating obstructions or strictures in the esophagus. These devices are intended to provide mechanical support and restore patency in the airway, addressing conditions such as malignant or benign strictures.
The company’s esophageal stents are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identification (UDI) system. 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 BCM Co., Ltd. manufacture?
BCM Co., Ltd. specializes in polymer-metal esophageal stents. These devices are specifically designed to treat obstructions or strictures in the esophagus, providing mechanical support to restore proper airway patency. The stents are intended for conditions like malignant or benign strictures, helping patients regain normal swallowing function.
Where is BCM Co., Ltd. based?
BCM Co., Ltd. is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards, which govern the development, manufacturing, and distribution of its medical devices.
In which regulatory registries are BCM Co., Ltd.’s devices listed?
BCM Co., Ltd.’s polymer-metal esophageal stents are included in the FDA’s Unique Device Identification (UDI) system. This registry helps track and identify medical devices in the U.S. market, ensuring transparency and traceability for healthcare providers and regulators.
How are BCM Co., Ltd.’s esophageal stents classified under U.S. regulations?
BCM Co., Ltd.’s polymer-metal esophageal stents fall under Class II classification according to FDA regulations. This classification is assigned based on the device’s intended use and associated risks, requiring special controls beyond general controls to ensure safety and effectiveness before authorization.
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
- 690134873
Catalogue (30)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HILZO Esophageal stents | EVP2006FC2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP2008HCS2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP1809FC2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP2007FC2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP2015HCS2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP2010HUS2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP2006HUS2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP1814FC2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP2015HUS2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP2010FC2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP1808FC2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP2006HCS2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP2014FC2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP2012FC2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP1812FC2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP2015FC2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP1807FC2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP2008FC2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP1813FC2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP2008HUS2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP1810FC2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP1811FC2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP1815FC2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP2013FC2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP2011FC2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP1806FC2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP2012HCS2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP2009FC2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP2012HUS2 | FDA UDI | Class II | Active |
| HILZO Esophageal stents | EVP2010HCS2 | FDA UDI | Class II | Active |
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