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Suzhou Shenyun Medical Equipment Co., Ltd.

Medical device manufacturer · Suzhou · China

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About Suzhou Shenyun Medical Equipment Co., Ltd.

Suzhou Shenyun Medical Equipment Co., Ltd. (SHENYUN) is a manufacturer of single-use medical devices based in Wuzhong District, Suzhou, China, close to Shanghai. Established in 2020, we have 100+ staff and a 4,000 m² facility with a Class 10,000 clean room, and export to 50+ countries. Our product lines cover bariatric surgery (gastric calibration tubes, intragastric balloon), surgical drainage (silicone drainage tubes, negative pressure drainage sets, vacuum suction bulbs), urinary and incontinence care (silicone Foley catheters, male external catheters, fecal management kits) and medical-grade silicone tubing. Our quality management system is certified to ISO 13485 by SGS. Our sterile gastric calibration tube, drainage tube and urinary catheter are CE-certified under EU MDR as Class IIa devices. Our gastric calibration tube is registered in Saudi Arabia (SFDA). We support OEM, private labeling and distributor cooperation.

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Company-supplied certifications

EU MDR CE (Class IIa: gastric calibration tube, drainage tube, urinary catheter), ISO 13485:2016

These are company-level statements, not certification of every listed product.

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