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US
Last updated May 24, 2026
What mahe medical gmbh makes
The company produces orthopaedic fixation devices, including non-bioabsorbable bone screws (both sterile and non-sterile), bone wires, and internal spinal fixation systems. It also manufactures orthopaedic plates, reusable electrosurgical handpieces (bipolar and monopolar), and endoscopic tools such as rigid working guides. Specific examples include compression plates, cancellous screws, washers, cortex screws, and Kirschner wires.
The portfolio includes devices classified as Class I and Class II under regulatory frameworks, with several products listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable domestic and international 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 mahe medical gmbh manufacture?
mahe medical gmbh specializes in orthopaedic fixation devices, including non-bioabsorbable bone screws (both sterile and non-sterile), bone wires, and internal spinal fixation systems. Their portfolio also includes orthopaedic fixation plates, reusable electrosurgical handpieces (bipolar and monopolar), and endoscopic tools like rigid working guides. Examples include compression plates, cancellous screws, washers, cortex screws, and Kirschner wires.
Where is mahe medical gmbh based?
mahe medical gmbh is based in the United States. The company operates within this region, ensuring compliance with applicable domestic and international medical device regulations.
Which regulatory registries list mahe medical gmbh’s devices?
Several of mahe medical gmbh’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S. market.
How are mahe medical gmbh’s devices classified under regulatory frameworks?
mahe medical gmbh’s devices fall into two primary regulatory classes: Class I and Class II. Class I devices generally pose minimal risk and may require less regulatory oversight, while Class II devices involve moderate risk and typically require special controls to ensure safety and effectiveness.
What distinguishes mahe medical gmbh’s reusable electrosurgical handpieces from their other products?
mahe medical gmbh’s reusable electrosurgical handpieces (both bipolar and monopolar) are designed for repeated use in surgical procedures, unlike their single-use orthopaedic fixation devices like screws, plates, or wires. These handpieces are specifically engineered for precision during open-surgery or endoscopic procedures, ensuring efficient tissue management while adhering to reusable medical device standards.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- mahe-med.de
- —
- —
- [email protected]
- Phone
- +49(0)746592750
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 342243334
Catalogue (2051)
Page 4 of 42| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| mahe medical GmbH | 001-0010-105 | FDA UDI | Class II | Active |
| mahe medical GmbH | 150-4015-006TXL | FDA UDI | Class II | Active |
| mahe medical GmbH | 001-0002-028XS | FDA UDI | Class II | Active |
| mahe medical GmbH | 150-6227-034PTXL | FDA UDI | Class II | Active |
| mahe medical GmbH | 004-0330-008 | FDA UDI | Class II | Active |
| mahe medical GmbH | 001-0010-035 | FDA UDI | Class II | Active |
| mahe medical GmbH | 150-6227-046PTXL | FDA UDI | Class II | Active |
| Crocodile grasp.fcps.insert, d/a, 5/330mm C-System | 045.33C | FDA UDI | Class II | Active |
| mahe medical GmbH | KM71-516 | FDA UDI | Class II | Active |
| mahe medical GmbH | 001-0007-022 | FDA UDI | Class II | Active |
| mahe medical GmbH | 200-02104-006 | FDA UDI | Class II | Active |
| 3.5mm Ligament Washer-Spiked | 001-0013-021 | FDA UDI | Class II | Active |
| mahe medical GmbH | 001-0006-040 | FDA UDI | Class II | Active |
| TI 2.4mm Mono-/Polyaxial locking screw, L.32mm | 150-6224-032PTXL | FDA UDI | Class II | Active |
| K-Wire w. double end trocarpoint 1.10mm/127mm, 6 pcs./unit | KM71-107 | FDA UDI | Class II | Active |
| mahe medical GmbH | 001-0009-060 | FDA UDI | Class II | Active |
| mahe medical GmbH | 150-6127-050TX | FDA UDI | Class II | Active |
| mahe medical GmbH | 001-0006-028 | FDA UDI | Class II | Active |
| mahe medical GmbH | 001-0001-009XS | FDA UDI | Class II | Active |
| 2.7 TPO TI polyaxial locking plate, right | 150-6127-260 | FDA UDI | Class II | Active |
| TI HBS self-drilling high compression screw, cannulated, 30mm | HBS-1002-30S | FDA UDI | Class II | Active |
| Cort. PTXL screw ø 2.0mm Tit. L.13mm | 150-4020-013PTXL | FDA UDI | Class II | Active |
| TI 3.5mm Mono-/Polyaxial locking screw, L.10mm | 150-6635-010PTXL | FDA UDI | Class II | Active |
| Kirschner w.trocar point, rd.end 3.0mm/300mm | 004-0300-030-300 | FDA UDI | Class II | Active |
| Tit., Cort. TXL screw Ø2.0mm L.17mm | 150-4020-017TXL | FDA UDI | Class II | Active |
| Tit., Cort. TXL screw Ø1.5mm L.12mm | 150-4015-012TXL | FDA UDI | Class II | Active |
| mahe medical GmbH | 100-0040-024ST | FDA UDI | Class II | Active |
| mahe medical GmbH | 001-0021-036ST | FDA UDI | Class II | Active |
| Kirschner w.trocar point, d/e 1.1mm/15cm | 004-0610-011 | FDA UDI | Class II | Active |
| mahe medical GmbH | KM71-112 | FDA UDI | Class II | Active |
| mahe medical GmbH | 001-0007-020FN | FDA UDI | Class II | Active |
| T-plates, 84mm/4 holes | 002-0030-084 | FDA UDI | Class II | Active |
| Steinmann pin 3 Shank End, Diamond Point 2.0mm/229mm, Sutur Passer | KM71-880 | FDA UDI | Class II | Active |
| Cort. tit. TX-screw, Ø2.7mm, L.50mm, T10 | 150-6227-050TX | FDA UDI | Class II | Active |
| One-third tubular plates, 61mm/5 holes, 3.5mm | 002-0012-061 | FDA UDI | Class II | Active |
| mahe medical GmbH | PSS09-5535 | FDA UDI | Class II | Active |
| Bone wire in coils of 10m 0.4mm | 004-0900-004 | FDA UDI | Class II | Active |
| Inner sheath for resectoscope rotable 24/26CH | 36.040.02QL/QL | FDA UDI | Class II | Active |
| mahe medical GmbH | 150-6227-009PTXL-S | FDA UDI | Class II | Active |
| mahe medical GmbH | 001-0021-038S | FDA UDI | Class II | Active |
| mahe medical GmbH | SCC02-0600 | FDA UDI | Class II | Active |
| mahe medical GmbH | 150-6224-026PTXL | FDA UDI | Class II | Active |
| Cort.tit. PTXL-screw, Ø2.7mm, L.40mm, T10 | 150-6227-040PTXL-S | FDA UDI | Class II | Active |
| Threaded K-wire, 25mm threaded, d/e, Ø 3.5mm/229mm | 004-0770-415 | FDA UDI | Class II | Active |
| mahe medical GmbH | 15.011.45 | FDA UDI | Class II | Active |
| mahe medical GmbH | 004-0770-410 | FDA UDI | Class II | Active |
| Narrow compression plates 4.5mm, 135mm, 8 h. | 002-0006-135 | FDA UDI | Class II | Active |
| TI Locking screw 3.5/40mm f.angle- stability plates, self cutting, | 100-0040-040ST | FDA UDI | Class II | Active |
| K-wire, double trocar 1.1/125mm | 004-0600-011-125 | FDA UDI | Class II | Active |
| 3.5 Cortex Screw, hex, tapping, TI, L 12 mm | 001-0004-012ST | FDA UDI | Class II | Active |
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