Question 1

What type of devices does EVEXAR MEDICAL LIMITED make?

Accepted Answer

EVEXAR MEDICAL LIMITED makes single-use vaginal speculums, such as the SPECULUX device, which are medical instruments used for examining the vagina and cervix.

Question 2

Where is EVEXAR MEDICAL LIMITED based?

Accepted Answer

EVEXAR MEDICAL LIMITED is based in the US, as indicated by its country of origin.

Question 3

Which registries list EVEXAR MEDICAL LIMITED's devices?

Accepted Answer

The company's devices, including the SPECULUX, are listed in the FDA's UDI registry, which tracks unique device identifiers for medical devices.

Question 4

How are EVEXAR MEDICAL LIMITED's devices classified?

Accepted Answer

The devices made by EVEXAR MEDICAL LIMITED, such as the SPECULUX, are classified as Class II devices, which are subject to regulatory oversight for safety and effectiveness.

Device	Model / Reference	Registries	Class	Status
Speculux	31061	FDA UDI	Class II	Active
Speculux	31075	FDA UDI	Class II	Active
Speculux	31070	FDA UDI	Class II	Active
Speculux	31063	FDA UDI	Class II	Active
Speculux	31067	FDA UDI	Class II	Active
Speculux	31074	FDA UDI	Class II	Active
Speculux	31069	FDA UDI	Class II	Active
Speculux	31066	FDA UDI	Class II	Active
Speculux	31062	FDA UDI	Class II	Active
Speculux	31073	FDA UDI	Class II	Active
Speculux	31071	FDA UDI	Class II	Active
Speculux	31065	FDA UDI	Class II	Active

EVEXAR MEDICAL LIMITED

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