6082015CE01
| EU Quality Management System Certificate Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III | |||
| Manufacturer: | Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road, Nanjing National Hi-Tech Industrial Development Zone 210032 Nanjing, Jiangsu Province P. R. China SRN ID.: CN-MF-000006950 | ||
| Active non-implantable imaging devices utilising non-ionizing radiation (MDA0202, class IIa) | |||
| Device name | - Single-Use Video Bronchoscopes - Digital Controllers - Single-Use Video Pancreaticobiliary Scopes - PB Digital Controllers | ||
| Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools (MDN 1203, class IIa) | |||
| Device name | - Sterile Biliary Stone Retrieval Balloon Catheter (including Retrieval Balloon / short-wire compatible) - Biliary Plastic Stent Introducer (Biliary Plastic Stent Introducer, Biliary Plastic Stent Introducer/ short-wire compatible) - Dilation Balloon - Disposable Multistage Dilation Balloon Catheter - Non Vascular Sterile Hydro Slide Guidewire | ||
| Non-active non-implantable instruments (MDN 1208, class IIa) | |||
| Device name | - Extraction Basket (including Extraction Basket/short-wire compatible) - Nitinol Spiral Extraction Basket (including Nitinol Spiral Extraction Basket/short-wire compatible) - Injection Needle - Single-Use SD Biopsy Forceps - Single-Use Biopsy Forceps - Sterile Elastic Traction Device - Extraction Basket | ||
| SPHINCTEROTOMES (G030402, class IIb) | |||
Device name: - Sphincterotome / short-wire compatible - Sphincterotome | Intended Purpose: The device is intended to be used with endoscope and guidewire for selective cannulation of the biliary ducts and monopolar cutting in sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi using high-frequency current. The device can also be used to inject contrast medium. | ||
| Esophageal Prostheses-Other (P050199, class IIb implantable) | |||
| Device name: - Esophageal Stent | Intended Purpose: The Esophageal Stent implant is indicated for use in the palliative treatment of esophageal stricture caused by malignant neoplasms, cardia stricture, anastomotic stoma stricture, and the esophageal fistula occluding. | ||
| NASO-BILIARY-PANCREATIC TUBES (G030403, class IIb implantable) | |||
| Device Name: - Biliary Plastic Stent Set/ short-wire compatible | Intended Purpose: The Biliary Plastic Stent Set/ short-wire compatible is used to drain obstructed biliary ducts. | ||
| Status: Valid | |||