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Sign in to claim this brandFENTEX medical GmbH
US
Last updated May 24, 2026
What FENTEX medical GmbH makes
FENTEX medical GmbH manufactures reusable surgical instruments for otolaryngology (ENT) and orthopaedic procedures, including soft-tissue cutting forceps, irrigation/aspiration cannulas, reusable probes, ear speculums, and middle ear picks. Their portfolio also includes reusable alligator-style manipulation forceps, osteotomes for bone cutting, and retraction system blades for surgical exposure.
All listed devices fall under Class I regulatory classification in the U.S. and are registered in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable U.S. medical device regulations.
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 FENTEX medical GmbH manufacture?
FENTEX medical GmbH specializes in reusable surgical instruments primarily used in otolaryngology (ENT) and orthopaedic procedures. Their product portfolio includes ENT soft-tissue cutting forceps, reusable irrigation/aspiration cannulas, reusable ENT probes, ear speculums, alligator-style soft-tissue manipulation forceps, orthopaedic osteotomes, reusable retraction system blades, and middle ear picks. These instruments are designed for precision and durability in surgical settings.
Where is FENTEX medical GmbH based?
FENTEX medical GmbH operates from the United States. The company’s location ensures compliance with U.S. medical device regulations, including registration and reporting requirements for devices marketed in the country.
Which regulatory registries list FENTEX medical GmbH’s devices?
FENTEX medical GmbH’s devices are registered in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I devices, which are generally considered low-risk but still subject to regulatory oversight in the U.S.
How are FENTEX medical GmbH’s devices classified under U.S. regulations?
All of FENTEX medical GmbH’s listed devices fall under Class I regulatory classification in the U.S. This classification applies to low-risk devices that pose minimal potential harm to patients. Class I devices typically require general controls (e.g., manufacturing practices, labeling) but may not need pre-market approval or clinical trials, depending on their specific use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- fentexmedical.com
- —
- —
- [email protected]
- Phone
- +4974679496212
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 507221724
Catalogue (2634)
Page 4 of 53| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Fentex | 054403FX | FDA UDI | Class I | Active |
| Fentex | 100513FX | EUDAMEDFDA UDI | Class I | Active |
| Fentex | 442718FX | FDA UDI | Class I | Active |
| Fentex | 270060FX | FDA UDI | Class I | Active |
| Fentex | 424921FX | FDA UDI | Class I | Active |
| Fentex | 156806FX | FDA UDI | Class I | Active |
| Fentex | 163206FX8 | FDA UDI | Class I | Active |
| Fentex | 228603FX | EUDAMEDFDA UDI | Class I | Active |
| Fentex | 234500FX | FDA UDI | Class I | Active |
| Fentex | 585445FX | FDA UDI | Class I | Active |
| Fentex | 054602FX | FDA UDI | Class I | Active |
| Fentex | 402602FX | FDA UDI | Class I | Active |
| Fentex | 230101FX | FDA UDI | Class I | Active |
| Fentex | 159104FX | EUDAMEDFDA UDI | Class I | Active |
| Fentex | 058100FX | FDA UDI | Class I | Active |
| Fentex | 426710FX | FDA UDI | Class I | Active |
| Fentex | 116512FX | EUDAMEDFDA UDI | Class I | Active |
| Fentex | 532250FX | FDA UDI | Class I | Active |
| Fentex | 532252FX | EUDAMEDFDA UDI | Class I | Active |
| Fentex | 532110FX | FDA UDI | Class I | Active |
| Fentex | 164500FX | FDA UDI | Class I | Active |
| Fentex | 116117FX | FDA UDI | Class I | Active |
| Fentex | 054500FX | FDA UDI | Class I | Active |
| Fentex | 112217FX | FDA UDI | Class I | Active |
| Fentex | 226302FX | FDA UDI | Class I | Active |
| Fentex | 085419FX | FDA UDI | Class I | Active |
| Fentex | 041702FX | FDA UDI | Class I | Active |
| Fentex | 150132FX | FDA UDI | Class I | Active |
| Fentex | 054530FX | FDA UDI | Class I | Active |
| Fentex | 151601FX | FDA UDI | Class I | Active |
| Fentex | 025103FX | EUDAMEDFDA UDI | Class I | Active |
| Fentex | 532203FX | FDA UDI | Class I | Active |
| Fentex | 113118FX | FDA UDI | Class I | Active |
| Fentex | 023721FX | FDA UDI | Class I | Active |
| Fentex | 540520FX | FDA UDI | Class I | Active |
| Fentex | 083212FX | FDA UDI | Class I | Active |
| Fentex | 185110FX | FDA UDI | Class I | Active |
| Fentex | 156112FX8 | EUDAMEDFDA UDI | Class I | Active |
| Fentex | 442818FX | FDA UDI | Class I | Active |
| Fentex | 353700FX | FDA UDI | Class I | Active |
| Fentex | 353503FX | FDA UDI | Class I | Active |
| Fentex | 532164FX | FDA UDI | Class I | Active |
| Fentex | 531712FX | FDA UDI | Class I | Active |
| Fentex | 018814FX | FDA UDI | Class I | Active |
| Fentex | 310105FX | FDA UDI | Class I | Active |
| Fentex | 086416FX | FDA UDI | Class I | Active |
| Fentex | 307908FX | FDA UDI | Class I | Active |
| Fentex | 241190FX | FDA UDI | Class I | Active |
| Fentex | 052800FX | FDA UDI | Class I | Active |
| Fentex | 532156FXF | FDA UDI | Class I | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Fentexmedical Gmbh NEUHAUSEN, BW Baden-Wurttemberg · DE FEI 3006154292