Question 1

What types of medical devices does Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. manufacture?

Accepted Answer

Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. specializes in non-portable electronic medical devices. Their primary products include automated blood pressure monitors (automatic-inflation electronic sphygmomanometers), infrared thermometers for measuring ear and skin temperature, bioelectrical impedance analysers for body composition analysis, and pulse oximeters for oxygen saturation monitoring. These devices are designed for clinical and consumer use in health monitoring.

Question 2

Where is Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. based, and does it operate in the United States?

Accepted Answer

The company is based in Shenzhen, China, but it has a presence in the United States. While the headquarters and primary manufacturing may be located abroad, their devices are distributed and used in the U.S., where they are subject to regulatory requirements like the FDA’s Unique Device Identifier (UDI) database listing.

Question 3

Which regulatory registries or databases list devices manufactured by Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.?

Accepted Answer

Devices from Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the United States, ensuring transparency and traceability for healthcare providers and regulators.

Question 4

How are the devices produced by Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. classified under regulatory standards?

Accepted Answer

The devices manufactured by Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. fall under Class II classification in regulatory frameworks. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness, such as automated blood pressure monitors, infrared thermometers, and pulse oximeters.

Device	Model / Reference	Registries	Class	Status
Portal724	TE-91	FDA UDI	Class II	Active
Contact Health	ePA-08B4	FDA UDI	Class II	Active
Thermometer	EQ-HW-TH-150-DI	FDA UDI	Class II	Active
Bytech	EQ-HW-TH-150-DI	FDA UDI	Class II	Active
eufy	T9140	FDA UDI	Class II	Active
Wifi Smart Scale	EF-804W	FDA UDI	Class II	Active
Thermometer	EQ-HW-TH-100-PD	FDA UDI	Class II	Active
Eufy	EF-706B4	FDA UDI	Class II	Active
cofoe	KF-103	FDA UDI	Class II	Active
Thermometer	EQ-HW-TH-150-DI	FDA UDI	Class II	Active
Belter	PA-52	FDA UDI	Class II	Active
Bytech	EQ-HW-TH-150-DI	FDA UDI	Class II	Active
biotricity	EPA-10B5	FDA UDI	Class II	Active
Rite Aid	TE-97	FDA UDI	Class II	Active
Rite Aid	TE-97	FDA UDI	Class II	Active
Innotech	YM201	FDA UDI	Class II	Active
Motorola	TE-93	FDA UDI	Class II	Active
doctorgram	eTE-89B4	FDA UDI	Class II	Active
cofoe	KF-102	FDA UDI	Class II	Active

Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.

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