Evacuator, Bladder, Manually Operated

Which Manufacturers in China Make This?

3 manufacturers in China hold an FDA registration for this device type, based in Jiangsu and Guangdong.

Changshu Rozer Sterilization Technology Co., Ltd. Jiangsu, contract manufacturer
Ucomfor Scientific Co., Ltd. Jiangsu, contract manufacturer
Well Lead Medical Co., Ltd. Guangdong, contract manufacturer

How Is FFD Classified?

Evacuator, Bladder, Manually Operated is FDA product code FFD, Class 1, 21 CFR 876.4370.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

Evacuator, Bladder, Manually Operated

Dual Action Pump Foot

The Dual Action Pump (DAP) is a user-controlled manual pump that delivers a bolus of irrigation fluid to the upper urinary tract during stone management, while simultaneously draining the…

Evacuator, Bladder, Manually Operated

Millennium

Ellik Rubber Ball Only

Evacuator, Bladder, Manually Operated

4 catalogue numbers from STS-URO-400-05-SET, listed by American Medical Endoscopy, United States, under Evacuator, Bladder, Manually Operated. 3 manufacturers in China are registered for this product code.

Evacuator, Bladder, Manually Operated

Hermann Medizintechnik GmbH

Luer-Lock tube connectionwith stopcock

Evacuator, Bladder, Manually Operated

Dual Action Pump Hand

The Dual Action Pump (DAP) is a user-controlled manual pump that delivers a bolus of irrigation fluid to the upper urinary tract during stone management, while simultaneously draining the…

Evacuator, Bladder, Manually Operated