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Sign in to claim this brandCnc Technologies
US
Last updated May 27, 2026
What Cnc Technologies makes
Cnc Technologies manufactures single-use electrosurgical handpieces designed for surgical procedures. Their primary product, the Duoblade series, includes variants such as the Duoblade Plus SE and Duoblade Prime, which are intended for precise tissue cutting and coagulation in operating environments.
The company’s devices fall under FDA Class II regulation and are authorised through 510(k) clearances and the FDA’s Unique Device Identification (UDI) system. These products are listed in the U.S. regulatory database under these frameworks.
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 Cnc Technologies manufacture?
Cnc Technologies specializes in single-use electrosurgical handpieces. These devices are specifically designed for surgical applications, enabling precise tissue cutting and coagulation during procedures. The company’s primary focus is on the Duoblade series, which includes multiple variants tailored for operating room use.
Where is Cnc Technologies based, and how does that affect its regulatory standing?
Cnc Technologies is based in the United States. As a U.S.-based manufacturer, its devices are subject to FDA regulations. The company’s products are authorised through the FDA’s 510(k) clearance process and are listed under the Unique Device Identification (UDI) system, ensuring compliance with U.S. medical device requirements.
Which regulatory registries or databases list Cnc Technologies’ devices?
Cnc Technologies’ devices are listed in the FDA’s regulatory databases, specifically through the 510(k) clearance pathway and the FDA’s Unique Device Identification (UDI) system. These registries ensure transparency and traceability of the company’s authorised electrosurgical handpieces, including the Duoblade series.
How are Cnc Technologies’ devices classified under FDA regulations?
Cnc Technologies’ electrosurgical handpieces fall under FDA Class II classification. This classification is assigned based on the level of risk associated with the device. Class II devices require special controls in addition to general controls to ensure their safety and effectiveness, which is why they undergo 510(k) clearance before being authorised for market.
What is the primary purpose of the Duoblade series of devices manufactured by Cnc Technologies?
The Duoblade series, including variants like the Duoblade Plus SE and Duoblade Prime, is designed for surgical procedures where precise tissue manipulation is required. These single-use electrosurgical handpieces are engineered to provide controlled cutting and coagulation, reducing the risk of complications during operations and improving surgical outcomes.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- cresen.co
- —
- —
- [email protected]
- Phone
- 619 356 0583
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 695063601
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Duoblade | DB1SEP | FDA UDI | Class II | Active |
| Duoblade | DB1SEP-H | FDA UDI | Class II | Active |
| Duoblade | DB1SP-T | FDA UDI | Class II | Active |
| Duoblade | DB1SEP-T | FDA UDI | Class II | Active |
| Duoblade | DB1SP-TH | FDA UDI | Class II | Active |
| Duoblade | DB1SP | FDA UDI | Class II | Active |
| Duoblade | DB1SP-H | FDA UDI | Class II | Active |
| Duoblade | K220996 | FDA 510(k)FDA UDI | Class II | Active |
| Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH) | K252211 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Cnc Technologies GWANGMYEONG-SI Gyeonggi · KR FEI 3009486890