6129531CE01
EU Quality Management System Certificate Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III | |
Manufacturer | Jiangsu Ate Medical Technology Co., Ltd. No.8, Lanxiang Road, Wujin Economic Development Zone 213149 Changzhou, Jiangsu P.R. China SRN ID.: CN-MF-000012853 |
device(s) / groups of device(s): | |
Non-active non-implantable devices instruments (MDN1208, class Is) Sterilization method: EtO | |
Device Name: - Disposable Endoscope Valves Sets - Disposable Biopsy Valves | |
DIGESTIVE ENDOSCOPY, HAEMOSTASIS CLIPS (G030202, class IIb implantable) | |
Device Name: - Hemostatic Clips | Intended Purpose: The Hemostatic Clips is indicated for clip placement within the Gastro-intestinal (GI) tract for the purpose of Hemostasis for: Mucosal/sub-mucosal defects <3 cm, Polyps <1.5 cm in diameter. |
Status | Valid |