ISO 13485 manufacturer of single-use medical devices: bariatric, drainage, urology & silicone tubing. Suzhou, China.
ISO 13485 manufacturer of single-use medical devices: bariatric, drainage, urology & silicone tubing. Suzhou, China.
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 (Saudi MDMA registration MDMA-2-2024-1267).
19 listed products
100% silicone urinary catheter for urethral catheterization and bladder drainage. Latex-free. No hydrophilic or silver coating. EO sterilized, single use. Specifications: SY03-08 to SY03-26 (8-26 Fr); balloon 3-5 ml / 5-10 ml / 30 ml Material: 100% silicone Certificates: EU MDR CE Class IIa (SGS NB 1639, cert. CN25/00007163); ISO 13485:2016 (SGS, CN25/00005189)
Medical Equipment
Guide needle used to lead the drainage tube through the skin during closed wound drainage placement. Matches the company's silicone drainage tubes. Certificates: ISO 13485:2016 (SGS, CN25/00005189)
Medical Equipment
Negative-pressure silicone drainage bulb, a core component of post-operative closed drainage systems, for draining blood, exudate and other fluids from body cavities. Available in 100 ml and 200 ml, top or bottom outlet. Specifications: CP-0127 to CP-0130; 100 ml / 200 ml; top outlet or bottom outlet Material: Medical-grade silicone Certificates: ISO 13485:2016 (SGS, CN25/00005189)
Closed-wound negative pressure drainage set for post-operative drainage of blood and exudate. Configurations: Type I drainage tube + vacuum suction ball; Type II drainage tube + guide needle; Type III drainage tube + guide needle + vacuum suction ball; Type IV drainage tube + guide needle + vacuum suction ball + drainage bag. EO sterilized, single use. Specifications: Type I-IV configurations; drainage tube 8-24 Fr; suction bulb 100/200 ml Certificates: ISO 13485:2016 (SGS, CN25/00005189)
Medical Equipment
Medical-grade silicone surgical drainage tube with T-structure (main tube + side arms) that stays fixed in the cavity, e.g. biliary tract. Used to drain fluid and blood from body cavities or wounds after general, thoracic, orthopedic and other surgery. Soft, biocompatible, low tissue irritation. EO sterilized, single use. Material: Medical-grade silicone Certificates: EU MDR CE Class IIa (SGS NB 1639, cert. CN25/00007163); ISO 13485:2016 (SGS, CN25/00005189)
Medical Equipment
Medical-grade silicone surgical drainage tube with soft flat profile that reduces tissue friction and fits the body cavity. Used to drain fluid and blood from body cavities or wounds after general, thoracic, orthopedic and other surgery. Soft, biocompatible, low tissue irritation. EO sterilized, single use. Specifications: CP-1633 to CP-1638; length 1010-1060 mm Material: Medical-grade silicone Certificates: EU MDR CE Class IIa (SGS NB 1639, cert. CN25/00007163); ISO 13485:2016 (SGS, CN25/00005189)
Medical Equipment
Medical-grade silicone surgical drainage tube with spiral design. Used to drain fluid and blood from body cavities or wounds after general, thoracic, orthopedic and other surgery. Soft, biocompatible, low tissue irritation. EO sterilized, single use. Specifications: CP-1610 to CP-1620; 8-24 Fr; length 1200 mm Material: Medical-grade silicone Certificates: EU MDR CE Class IIa (SGS NB 1639, cert. CN25/00007163); ISO 13485:2016 (SGS, CN25/00005189)
Medical Equipment
Medical-grade silicone surgical drainage tube with cross-shaped tip opening. Used to drain fluid and blood from body cavities or wounds after general, thoracic, orthopedic and other surgery. Soft, biocompatible, low tissue irritation. EO sterilized, single use. Specifications: CP-1599 to CP-1609; 8-24 Fr; length 1200 mm Material: Medical-grade silicone Certificates: EU MDR CE Class IIa (SGS NB 1639, cert. CN25/00007163); ISO 13485:2016 (SGS, CN25/00005189)
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