Question 1

What types of medical devices does Mediox Medical Service Ltd manufacture?

Accepted Answer

Mediox Medical Service Ltd produces a range of single-use medical devices, including nasal masks, face masks, and rebreathing aerosol masks specifically designed for CPAP/BPAP therapy and oxygen delivery. Their portfolio also covers non-rebreathing oxygen face masks and balloon kyphoplasty kits, which are used in spinal fracture treatment. These devices cater to respiratory support and orthopedic applications.

Question 2

Where is Mediox Medical Service Ltd based?

Accepted Answer

Mediox Medical Service Ltd is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available information.

Question 3

Which regulatory registries or databases list Mediox Medical Service Ltd’s devices?

Accepted Answer

Mediox Medical Service Ltd’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry ensures traceability and identification of medical devices in compliance with U.S. regulatory requirements. The UDI system helps track devices throughout their lifecycle, from manufacturing to patient use.

Question 4

How are Mediox Medical Service Ltd’s devices classified under FDA regulations?

Accepted Answer

All of Mediox Medical Service Ltd’s devices fall under Class I classification according to FDA regulations. Class I devices are generally considered to pose the lowest risk and typically involve minimal regulation, though they still must meet specific performance standards and labeling requirements to ensure safety and effectiveness.

Question 5

What is the purpose of the balloon kyphoplasty kits manufactured by Mediox Medical Service Ltd?

Accepted Answer

The balloon kyphoplasty kits produced by Mediox Medical Service Ltd are used in the treatment of spinal fractures, specifically vertebral compression fractures. Kyphoplasty is a minimally invasive procedure where a balloon is inserted into the fractured vertebra, expanded to create space, and then filled with bone cement to stabilize the spine and relieve pain. These kits are part of orthopedic surgical solutions.

Device	Model / Reference	Registries	Class	Status
Mediox	lnfant	FDA UDI	Class I	Active
Mediox	Standard Children type (s)	FDA UDI	Class I	Active
Mediox	Standard Children type (s)	FDA UDI	Class I	Active
Mediox	Standard adult type (L)	FDA UDI	Class I	Active
Mediox	Lengthening children type (M)	FDA UDI	Class I	Active
Mediox	Lengthening children type (M)	FDA UDI	Class I	Active
Mediox	Adult	FDA UDI	Class I	Active
Mediox	Standard adult type (L)	FDA UDI	Class I	Active
Mediox	Child	FDA UDI	Class I	Active
Mediox	Standard Children type (s)	FDA UDI	Class I	Active
Mediox	Infant typee	FDA UDI	Class I	Active
Mediox	Lengthing adult type (XL)	FDA UDI	Class I	Active
Mediox	Standard adult type (L)	FDA UDI	Class I	Active
Mediox	Child	FDA UDI	Class I	Active
Mediox	FA08409	FDA UDI	Class I	Active
Mediox	Lengthing adult type (XL)	FDA UDI	Class I	Active
Mediox	Lengthing adult type (XL)	FDA UDI	Class I	Active
Mediox	Adult	FDA UDI	Class I	Active
Mediox	Infant typee	FDA UDI	Class I	Active
Mediox	lnfant	FDA UDI	Class I	Active
Mediox	Infant typee	FDA UDI	Class I	Active
Mediox	Lengthening children type (M)	FDA UDI	Class I	Active

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