Question 1

What types of medical devices does Shanghai Medifriend Medical Products Co., Ltd. manufacture?

Accepted Answer

Shanghai Medifriend Medical Products Co., Ltd. specializes in blood pressure monitoring devices. Specifically, they produce the Medifriend Professional Sphygmomanometer, which is designed for measuring both systolic and diastolic blood pressure in clinical and home settings. This device supports both manual and automated readings to provide accurate monitoring.

Question 2

Where is Shanghai Medifriend Medical Products Co., Ltd. based?

Accepted Answer

The company, Shanghai Medifriend Medical Products Co., Ltd., is based in the United States. This location is relevant for regulatory oversight and compliance with U.S. medical device standards.

Question 3

Which regulatory registries list devices manufactured by Shanghai Medifriend Medical Products Co., Ltd.?

Accepted Answer

The Medifriend Professional Sphygmomanometer, one of the company’s devices, is listed in the FDA’s 510(k) registry. This registry tracks medical devices that have undergone a premarket notification process, ensuring they meet applicable regulatory requirements before being marketed in the U.S.

Question 4

How are devices from Shanghai Medifriend Medical Products Co., Ltd. classified under U.S. regulations?

Accepted Answer

The Medifriend Professional Sphygmomanometer is classified as a Class II medical device under FDA regulations. This classification indicates a moderate level of risk, requiring special controls in addition to general controls to ensure safety and effectiveness. Class II devices are subject to stricter oversight than Class I but less than Class III.

Device	Model / Reference	Registries	Class	Status
PRIMAFIX™ Plus Conformable Retention Tape	6in.x10yd	FDA UDI	Class I	Active
Transparent Adhesive Film Dressing	TF12810	FDA UDI	Class I	Active
Transparent Adhesive Film Dressing	TF8610	FDA UDI	Class I	Active
PRIMAFIX™ Plus Conformable Retention Tape	4in.x10yd	FDA UDI	Class I	Active
PRIMAFIX™ Plus Conformable Retention Tape	2in.x2yd	FDA UDI	Class I	Active
EyePro™ Eyelid Covers	3.7cm x9.3cm	FDA UDI	Class I	Active
Transparent Adhesive Film Dressing	TF1285	FDA UDI	Class I	Active
PRIMAFIX™ Plus Conformable Retention Tape	6in.x2yd	FDA UDI	Class I	Active
PRIMAFIX™ Plus Conformable Retention Tape	4in.x2yd	FDA UDI	Class I	Active
Transparent Adhesive Film Dressing	TF447550	FDA UDI	Class I	Active
PRIMAFIX™ Plus Conformable Retention Tape	2in.x10yd	FDA UDI	Class I	Active
Transparent Adhesive Film Dressing	TF2250	FDA UDI	Class I	Active
Transparent Adhesive Film Dressing	TF8620	FDA UDI	Class I	Active
Transparent Adhesive Film Dressing	TF447520	FDA UDI	Class I	Active
Transparent Adhesive Film Dressing	TF4475100	FDA UDI	Class I	Active
Transparent Adhesive Film Dressing	TF22100	FDA UDI	Class I	Active
Medifriend Professional Sphygmomanometer	K950778	FDA 510(k)	Class II	Active

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