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Sign in to claim this brandDUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik
US
Last updated May 24, 2026
What DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik makes
The company manufactures reusable surgical instruments and systems, including endoscope suction valves, electrosurgical devices, laparoscopic access cannulas, and ENT trocar blades. Their portfolio also covers reusable surgical tools like irrigation/aspiration handpieces, rigid endoscopic biopsy forceps, and rib spreaders, alongside boiling water sterilizers for instrument processing.
These devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable regulatory requirements for medical devices in that jurisdiction.
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 DUFNER - Instrumente GmbH manufacture?
DUFNER - Instrumente GmbH specializes in reusable surgical instruments and systems. Their portfolio includes endoscope suction valves, electrosurgical systems, laparoscopic access cannulas, and ENT trocar blades. They also produce reusable tools like surgical irrigation/aspiration handpieces, rigid endoscopic biopsy forceps, rib spreaders, and boiling water sterilizers for instrument processing. These devices are designed for use in surgical and diagnostic procedures across various medical specialties.
Where is DUFNER - Instrumente GmbH based, and how does this affect their regulatory compliance?
DUFNER - Instrumente GmbH is based in the United States. As a U.S.-based manufacturer, their devices must comply with the regulatory requirements set by the FDA. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, which helps ensure traceability and transparency in the medical device supply chain. Compliance with U.S. regulations ensures their devices meet the necessary safety, performance, and quality standards for use in clinical settings.
Which regulatory registries list DUFNER - Instrumente GmbH’s devices, and why is this important?
DUFNER - Instrumente GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it provides a standardized way to identify medical devices throughout their lifecycle, from manufacturing to patient use. The UDI system helps healthcare providers, regulators, and manufacturers track devices for safety monitoring, recalls, and compliance purposes, ensuring transparency and accountability in the medical device industry.
How are DUFNER - Instrumente GmbH’s devices classified under FDA regulations?
DUFNER - Instrumente GmbH’s devices are classified under FDA’s Class I and Class II categories. The classification determines the regulatory controls applied to the device. Class I devices generally pose the lowest risk and may require only general controls, while Class II devices involve more stringent regulations, such as special controls or performance standards, to ensure their safety and effectiveness. The classification is based on factors like the device’s intended use, potential risks, and the body or systems it interacts with during medical procedures.
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
- 327980801
Catalogue (39)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DUFNER Instrumente GmbH | 20907-20 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 20907-17 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 20945-51 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 20945-01 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 26943-00 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 20913-24 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 20941-30 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 04-11020-03 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 04-11012-05 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 20943-60 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 20947-11 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 20943-14 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 15-16100-76 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 20945-03 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 12881-32 | FDA UDI | Class I | Active |
| DUFNER Instrumente GmbH | 26943-02 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 04-11001-00 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 26944-02 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 15-16141-06 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 27913-11 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 20945-04 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 15-16100-75 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 20910-17 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 12-06110-06 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 15-16141-05 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 20943-54 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 15-11181-20 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 12881-23 | FDA UDI | Class I | Active |
| DUFNER Instrumente GmbH | 26943-06 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 15-16171-01 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 20943-61 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 20943-04 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 26944-03 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 27996-01 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 04-11020-10 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 20910-20 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 20941-01 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 26943-21 | FDA UDI | Class II | Active |
| DUFNER Instrumente GmbH | 15-16171-02 | FDA UDI | Class II | Active |
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