Question 1

What types of medical devices does mahe medical gmbh manufacture?

Accepted Answer

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.

Question 2

Where is mahe medical gmbh based?

Accepted Answer

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.

Question 3

Which regulatory registries list mahe medical gmbh’s devices?

Accepted Answer

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.

Question 4

How are mahe medical gmbh’s devices classified under regulatory frameworks?

Accepted Answer

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.

Question 5

What distinguishes mahe medical gmbh’s reusable electrosurgical handpieces from their other products?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
mahe medical GmbH	001-0012-045	FDA UDI	Class II	Active
mahe medical GmbH	001-0007-030	FDA UDI	Class II	Active
mahe medical GmbH	150-6227-040TX-S	FDA UDI	Class II	Active
mahe medical GmbH	KM71-182	FDA UDI	Class II	Active
mahe medical GmbH	150-6127-046TX	FDA UDI	Class II	Active
One third tubular locking plate, 97mm/8 holes	100-0700-008	FDA UDI	Class II	Active
mahe medical GmbH	PSS09-15530	FDA UDI	Class II	Active
mahe medical GmbH	150-6224-104	FDA UDI	Class II	Active
mahe medical GmbH	SCC02-0200	FDA UDI	Class II	Active
mahe medical GmbH	001-0008-056S	FDA UDI	Class II	Active
TI Locking screw 2.7/32mm f.angle- stability plates, self cutting,	100-0030-032ST	FDA UDI	Class II	Active
TI rod 6x55mm	SCC02-0055	FDA UDI	Class II	Active
mahe medical GmbH	150-6227-038TX-S	FDA UDI	Class II	Active
mahe medical GmbH	200-0224-756	FDA UDI	Class II	Active
mahe medical GmbH	150-6127-020TX	FDA UDI	Class II	Active
Obturator, 11mm	13.028.11	FDA UDI	Class II	Active
mahe medical GmbH	150-4020-016TXL	FDA UDI	Class II	Active
mahe medical GmbH	001-0007-036FN	FDA UDI	Class II	Active
mahe medical GmbH	PSR11-7545	FDA UDI	Class II	Active
mahe medical GmbH	150-4020-011TXL	FDA UDI	Class II	Active
2.4 TPLO SS polyaxial locking plate right	150-6224-200	FDA UDI	Class II	Active
mahe medical GmbH	001-0008-034S	FDA UDI	Class II	Active
Telescope bridge w.2 working channels, for 4.0mm optic	35.005.02	FDA UDI	Class II	Active
TI rod 6x70mm cvd.	SCC03-0070	FDA UDI	Class II	Active
mahe medical GmbH	150-6127-014PTXL	FDA UDI	Class II	Active
TI 2.4mm Mono-/Polyaxial locking screw, L.34mm	150-6224-034PTXL	FDA UDI	Class II	Active
K-Wire w. trocar/round end 0.89mm/229mm, 6 pcs./unit	KM71-151	FDA UDI	Class II	Active
mahe medical GmbH	HBS-1003-28S	FDA UDI	Class II	Active
mahe medical GmbH	100-0611-004	FDA UDI	Class II	Active
mahe medical GmbH	KW-1000-080	FDA UDI	Class II	Active
Cort. TXL screw Ø2.7mm Tit. L.18mm	150-6127-018TXL	FDA UDI	Class II	Active
Cort. TX screw Ø2.7mm Tit. L.16mm	150-6127-016TX-S	FDA UDI	Class II	Active
mahe medical GmbH	KM71-134	FDA UDI	Class II	Active
TI 2.4mm Mono-/Polyaxial locking screw, L.24mm	150-6224-024PTXL	FDA UDI	Class II	Active
3.5mm LCP Extra Articlr Distal Humerus Plate 6 Holes Rt. 158mm long	200-02104-006	FDA UDI	Class II	Active
mahe medical GmbH	100-0030-024ST	FDA UDI	Class II	Active
3.5 Cortex Screw, hex, St.Steel, L 26 mm	001-0004-026	FDA UDI	Class II	Active
mahe medical GmbH	SCC03-0160	FDA UDI	Class II	Active
Diss.-+grasp fcps.insert, heavy pattern, 5/330mm	008.33	FDA UDI	Class II	Active
6.5 Cancellous Bone Screw, hex, St.Steel, L 55 mm	001-0012-055	FDA UDI	Class II	Active
mahe medical GmbH	001-0010-080	FDA UDI	Class II	Active
Metal shaft w.shaft knob, 5/330mm	19.50/33	FDA UDI	Class II	Active
mahe medical GmbH	PSS08-4540	FDA UDI	Class II	Active
mahe medical GmbH	150-4300-116	FDA UDI	Class II	Active
Polyaxial screw, w/o cannulation, 6.5mm/60mm	PSS10-6560	FDA UDI	Class II	Active
2.0mm LCP (TM) condylar Plate 7 Holes	150-4300-116	FDA UDI	Class II	Active
TI HBS self-drilling high compression screw, cannulated, 32mm	HBS-1002-32S	FDA UDI	Class II	Active
Polyaxial screw reduct., w/o cannulation 7.5mm/55mm	PSR11-7555	FDA UDI	Class II	Active
mahe medical GmbH	001-0011-055	FDA UDI	Class II	Active
TI 3.5mm Mono-/Polyaxial locking screw, L.18mm	150-6635-018PTXL	FDA UDI	Class II	Active

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