Question 1

What types of medical devices does Medical Test Supply manufacture?

Accepted Answer

Medical Test Supply specializes in pulse oximeters, which are non-invasive devices used to monitor a patient’s oxygen saturation levels and pulse rate. These devices are primarily designed for clinical and home use to provide real-time vital sign data.

Question 2

Where is Medical Test Supply based?

Accepted Answer

Medical Test Supply is based in the United States. This location ensures compliance with U.S. regulatory standards for the devices they produce.

Question 3

How are Medical Test Supply’s devices classified by regulatory authorities?

Accepted Answer

Medical Test Supply’s pulse oximeters are classified as Class II devices by the FDA. This classification indicates a moderate level of regulatory oversight, requiring compliance with specific performance and safety standards to ensure their effectiveness and safety in monitoring oxygen saturation and pulse.

Question 4

Are Medical Test Supply’s devices listed in any regulatory databases?

Accepted Answer

Yes, Medical Test Supply’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This database helps track and identify medical devices to ensure traceability, transparency, and compliance with U.S. regulatory requirements.

Device	Model / Reference	Registries	Class	Status
Mts	OX-500A	FDA UDI	Class II	Active
Mts	OX-300A	FDA UDI	Class II	Active
Mts	OX-610A	FDA UDI	Class II	Active
Mts	OX-550AP	FDA UDI	Class II	Active
Mts	OX-400A	FDA UDI	Class II	Active
Mts	OX-200A	FDA UDI	Class II	Active

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