6122159CE01
| EU Quality Management System Certificate Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III | |||
| Manufacturer | Haiyan Kangyuan Medical Instrument Co., Ltd. Songpodong Road, Shendang Town 314311, Haiyan, Zhejiang China SRN ID.: CN-MF-000001532 | ||
| Non-active non-implantable devices for anaesthesia, emergency and intensive care (MDN1201, Class IIa) | |||
| Device(s)/Group of device(s) | - Endotracheal Tubes for Single Use - Sterile Suction Catheters for Single Use - Oxygen Masks for Single Use - Nasal Oxygen Cannulas for Single Use - Guedel Airways for Single Use - Laryngeal Mask Airways - Anesthesia Masks for Single Use - Breathing Filters for Single Use - Breathing Circuits for Single Use - PVC Laryngeal Mask Airways | ||
| URETERAL CATHETERS WITH BALLOON – OTHER (U020299, Class IIb) | |||
| Device Name: - Urinary Catheters for Single Use (Foley) - Latex Foley Catheters for Single Use | Intended Purpose: The product is intended to continuous urinate and douche urinary bladder by inserting into urinary bladder though urethra. | ||
| Status | Valid | ||