6082015CE01

Company	Micro-Tech (Nanjing) Co., Ltd.
Address	No.10 Gaoke Third Road, Nanjing National Hi-Tech Industrial Development Zone 210032 Nanjing, Jiangsu Province P. R. China
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
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.
Status: Valid