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.
Expiry date	1 September 2027