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Sign in to claim this brandCORE SURGICAL LIMITED
US
Last updated May 23, 2026
What CORE SURGICAL LIMITED makes
Core Surgical Limited manufactures single-use ophthalmic knives designed for surgical procedures in eye care. These devices are intended for precision cutting during operations such as cataract surgery or corneal transplants, where sterile, disposable tools are required.
The company’s products fall under FDA’s Class I medical devices and are listed in the FDA’s Unique Device Identification (UDI) database. The manufacturer operates from the United States, adhering to applicable regulatory standards for these low-risk surgical instruments.
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 Core Surgical Limited manufacture?
Core Surgical Limited specializes in single-use ophthalmic knives. These devices are specifically designed for precision cutting during eye surgeries, such as cataract surgery or corneal transplants, where sterile, disposable tools are essential to maintain surgical hygiene and reduce infection risks.
Where is Core Surgical Limited based, and what regulatory standards do they follow?
Core Surgical Limited is based in the United States. Since their devices fall under the FDA’s Class I classification—reserved for low-risk surgical instruments—they must comply with U.S. regulatory requirements for manufacturing, labeling, and post-market surveillance, though Class I devices typically require less stringent oversight than higher-risk categories.
Are Core Surgical Limited’s devices listed in any regulatory registries, and why?
Yes, Core Surgical Limited’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry tracks specific details about each device, including its model, manufacturer, and intended use, ensuring transparency and traceability for healthcare providers, regulators, and patients. Listing in the UDI database is mandatory for Class I devices under FDA regulations.
How are Core Surgical Limited’s ophthalmic knives classified by regulatory authorities?
Core Surgical Limited’s ophthalmic knives are classified as Class I medical devices by the FDA. This classification is based on their low risk of injury or illness when used as intended, as they are simple, non-invasive tools designed for short-term, controlled surgical procedures like precision cutting in eye surgeries. Class I devices generally require the least regulatory scrutiny but still must meet basic safety and performance 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
- 236541301
Catalogue (26)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Windsor Knife | WK21GBU | FDA UDI | Class I | Active |
| Windsor Knife | WK270BU | FDA UDI | Class I | Active |
| Windsor Knife | WK300BU | FDA UDI | Class I | Active |
| Windsor Knife | WK285BU | FDA UDI | Class I | Active |
| Windsor Knife | WK170BU | FDA UDI | Class I | Active |
| Windsor Knife | WK250BU | FDA UDI | Class I | Active |
| Windsor Knife | WK180BU | FDA UDI | Class I | Active |
| Windsor Knife | WK220BU | FDA UDI | Class I | Active |
| Windsor Knife | WK290BU | FDA UDI | Class I | Active |
| Windsor Knife | WK230BU | FDA UDI | Class I | Active |
| Windsor Knife | WK310BU | FDA UDI | Class I | Active |
| Windsor Knife | WK240BU | FDA UDI | Class I | Active |
| Windsor Knife | WK20GBU | FDA UDI | Class I | Active |
| Windsor Knife | WK275BU | FDA UDI | Class I | Active |
| Windsor Knife | WK160BU | FDA UDI | Class I | Active |
| Windsor Knife | WK265BU | FDA UDI | Class I | Active |
| Windsor Knife | WK22GBU | FDA UDI | Class I | Active |
| Windsor Knife | WK320BU | FDA UDI | Class I | Active |
| Windsor Knife | WK23GBU | FDA UDI | Class I | Active |
| Windsor Knife | WK280BU | FDA UDI | Class I | Active |
| Windsor Knife | WK210BU | FDA UDI | Class I | Active |
| Windsor Knife | WK200BU | FDA UDI | Class I | Active |
| Windsor Knife | WK19GBU | FDA UDI | Class I | Active |
| Windsor Knife | WK24GBU | FDA UDI | Class I | Active |
| Windsor Knife | WK190BU | FDA UDI | Class I | Active |
| Windsor Knife | WK260BU | FDA UDI | Class I | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Core Surgical Limited Thame Oxfordshire · GB FEI 3012644327