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EPflex Feinwerktechnik GmbH manufactures single-use urinary stone retrieval baskets designed for percutaneous nephrolithotomy (PCNL) procedures. These devices are intended for extracting kidney stones during minimally invasive surgical interventions.
The company’s products fall under FDA Class II regulation and are listed in the FDA’s Unique Device Identifier (UDI) database. 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 EPflex Feinwerktechnik GmbH manufacture?
EPflex Feinwerktechnik GmbH specializes in single-use urinary stone retrieval baskets. These devices are specifically designed for percutaneous nephrolithotomy (PCNL), a minimally invasive surgical procedure used to remove kidney stones. The focus is on retrieval tools for stone extraction during such interventions.
Where is EPflex Feinwerktechnik GmbH based?
The company is based in the United States. This location is relevant for regulatory oversight and compliance with local and international medical device regulations.
Which regulatory registries or databases list EPflex Feinwerktechnik GmbH’s devices?
EPflex Feinwerktechnik GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices for regulatory, clinical, and market surveillance purposes.
How are EPflex Feinwerktechnik GmbH’s devices classified under medical device regulations?
EPflex Feinwerktechnik GmbH’s urinary stone retrieval baskets fall under FDA Class II classification. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, beyond general controls.
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
- 312527765
Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Domia Front | DOF151 | FDA UDI | Class II | Active |
| Domia Front | DOF158 | FDA UDI | Class II | Active |
| Domia Front | DOF201 | FDA UDI | Class II | Active |
| Domia Front | DOF208 | FDA UDI | Class II | Active |
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