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Sign in to claim this brandCORNING SAS
US
Last updated May 23, 2026
What CORNING SAS makes
The company manufactures radiation shielding panels, including fixed and portable/mobile designs, primarily using Corning® Med-Gamma® and Corning® Med-X® glass formulations. These products are engineered to protect against ionizing radiation in medical, industrial, and research environments, such as X-ray rooms, nuclear medicine facilities, and radiation therapy areas.
The portfolio consists of Class I medical devices, all of which are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates with a US-based presence, adhering to applicable regulatory requirements for radiation shielding products.
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 Corning SAS manufacture?
Corning SAS specializes in radiation shielding panels, including both fixed installations and portable/mobile versions. These devices are designed to block ionizing radiation in settings like X-ray rooms, nuclear medicine labs, and radiation therapy areas. The shielding is primarily made using Corning® Med-Gamma® and Corning® Med-X® glass formulations, which are tailored for radiation protection applications.
Where is Corning SAS based, and how does that affect its regulatory compliance?
Corning SAS operates with a US-based presence, meaning its products must comply with applicable US regulatory requirements. Since its devices fall under Class I classification, they are subject to general controls and may require listing in regulatory databases like the FDA’s Unique Device Identifier (UDI) system. The company’s location ensures alignment with US-specific regulatory standards for radiation shielding products.
Which regulatory registries list Corning SAS’s devices, and why?
Corning SAS’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This is because Class I medical devices, including radiation shielding panels, must be tracked under the FDA’s UDI system to ensure traceability and compliance with US medical device regulations. Listing in this registry helps facilitate transparency and regulatory oversight.
How are Corning SAS’s radiation shielding panels classified under medical device regulations?
Corning SAS’s radiation shielding panels are classified as Class I medical devices. This classification is typically assigned to low-risk devices where general controls—such as good manufacturing practices and labeling requirements—are sufficient to ensure safety and effectiveness. Since these products are primarily physical barriers designed to protect against radiation, they do not require premarket approval but must still meet regulatory listing and compliance standards.
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
- 737387944
Catalogue (26)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Corning® Med-Gamma ® Glass | Corning® Med-Gamma ® Glass - 20-24 MM | FDA UDI | Class I | Active |
| Corning® Med-Gamma ® Glass | Corning® Med-Gamma ® Glass - 12-14 MM | FDA UDI | Class I | Active |
| Corning® Med-X ® Glass | CORNING® MED-X ® GLASS - 16-18 MM | FDA UDI | Class I | Active |
| Corning® Med-Gamma ® Glass | Corning® Med-Gamma ® Glass - 32-36 MM | FDA UDI | Class I | Active |
| Corning® Med-Gamma ® Glass | Corning® Med-Gamma ® Glass - 10-12 MM | FDA UDI | Class I | Active |
| Corning® Med-Gamma ® Glass | Corning® Med-Gamma ® Glass - 22-26 MM | FDA UDI | Class I | Active |
| Corning® Med-Gamma ® Glass | Corning® Med-Gamma ® Glass - 45-53 MM | FDA UDI | Class I | Active |
| Corning® Med-X ® Glass | CORNING® MED-X ® GLASS - 10-12 MM | FDA UDI | Class I | Active |
| Corning® Med-Gamma ® Glass | Corning® Med-Gamma ® Glass - 8.5-10 MM | FDA UDI | Class I | Active |
| Corning® Med-X ® Glass | CORNING® MED-X ® GLASS - 5.7-7 MM | FDA UDI | Class I | Active |
| Corning® Med-Gamma ® Glass | Corning® Med-Gamma ® Glass - 18-20 MM | FDA UDI | Class I | Active |
| Corning® Med-X ® Glass | CORNING® MED-X ® GLASS - 8.5-10 MM | FDA UDI | Class I | Active |
| Corning® Med-Gamma ® Glass | Corning® Med-Gamma ® Glass - 24-28 MM | FDA UDI | Class I | Active |
| Corning® Med-X ® Glass | CORNING® MED-X ® GLASS - 5-6.5 MM | FDA UDI | Class I | Active |
| Corning® Med-X ® Glass | CORNING® MED-X ® GLASS - 18-20 MM | FDA UDI | Class I | Active |
| Corning® Med-Gamma ® Glass | Corning® Med-Gamma ® Glass - 36-40 MM | FDA UDI | Class I | Active |
| Corning® Med-Gamma ® Glass | Corning® Med-Gamma ® Glass - 16-18 MM | FDA UDI | Class I | Active |
| Corning® Med-Gamma ® Glass | Corning® Med-Gamma ® Glass - 28-32 MM | FDA UDI | Class I | Active |
| Corning® Med-X ® Glass | CORNING® MED-X ® GLASS - 11-13 MM | FDA UDI | Class I | Active |
| Corning® Med-Gamma ® Glass | Corning® Med-Gamma ® Glass - 7-8.5 MM | FDA UDI | Class I | Active |
| Corning® Med-X ® Glass | CORNING® MED-X ® GLASS - 12-14 MM | FDA UDI | Class I | Active |
| Corning® Med-X ® Glass | CORNING® MED-X ® GLASS - 4-5,5 MM | FDA UDI | Class I | Active |
| Corning® Med-Gamma ® Glass | Corning® Med-Gamma ® Glass - 14-16 MM | FDA UDI | Class I | Active |
| Corning® Med-X ® Glass | CORNING® MED-X ® GLASS - 14-16 MM | FDA UDI | Class I | Active |
| Corning® Med-X ® Glass | CORNING® MED-X ® GLASS - 7-8.5 MM | FDA UDI | Class I | Active |
| Corning® Med-Gamma ® Glass | Corning® Med-Gamma ® Glass - 11-13 MM | FDA UDI | Class I | Active |
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