Singapore HSA registration DE0508318
Lexion Medical AP 50/30 HIGH FLOW INSUFFLATOR
Singapore·CLASS B·Lexion Medical, LLC·Registered July 21, 2023Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0508318
- Registration Date
- July 21, 2023
- Retention Due Date
- July 20, 2025
Product description
The AP50/30 Insufflator is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard/High Flow, Pediatric and Bariatric operating modes of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is specifically indicated for pediatric laparoscopic procedures. The Vessel Harvesting operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during trans anal minimal invasive surgery.
Product Owner
- Short Name
- Lexion Medical, LLC
- Address
- 545 Atwater Circle,, St. Paul, Minnesota 55103, UNITED STATES
Registrant
- Address
- 438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #06-03, SINGAPORE 119968
Importer
- Address
- 438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #06-03, SINGAPORE 119968
Model information
- Model Name(s)
- AP 50/30 High Flow Insufflator 10mm x 100mm Insuflow Gas Conditioning Port 10mm x 100 mm Insuflow Gas Conditioning Port and PneuView Laparoscopic Smoke Elimination Device 10mm x 130 mm Insuflow Gas Conditioning Port 10mm x 130 mm Insuflow Gas Conditioning Port and PneuView Laparoscopic Smoke Elimination Device 12mm x 100 mm Insuflow Gas Conditioning Port w/ Sample Removal 12mm x 100 mm Insuflow Gas Conditioning Port and PneuView Laparoscopic Smoke Elimination Device 12mm x 130 mm Insuflow Gas Conditioning Port 12mm x 130 mm Insuflow Gas Conditioning Port and PneuView Laparoscopic Smoke Elimination Device 5mm x 100 mm Insuflow Gas Conditioning Port 5mm x 100 mm Insuflow Gas Conditioning Port and PneuView Laparoscopic Smoke Elimination Device 5mm x 130 mm Insuflow Gas Conditioning Port 5mm x 130 mm Insuflow Gas Conditioning Port and PneuView Laparoscopic Smoke Elimination Device 8mm x 100 mm Insuflow Gas Conditioning Port 8mm x 100 mm Insuflow Gas Conditioning Port and PneuView Laparoscopic Smoke Elimination Device 8mm x 130 mm Insuflow Gas Conditioning Port 8mm x 130 mm Insuflow Gas Conditioning Port and PneuView Laparoscopic Smoke Elimination Device Insuflow Laparascopic Gas Conditioning Device PneuView Laparoscopic Smoke Elimination Device
- Model Identifier(s)
- 4100 4100-10 4100-10-XE 4100-10B 4100-10B-XE 4100-12 4100-12-XE 4100-12B 4100-12B-XE 4100-5 4100-5-XE 4100-5B 4100-5B-XE 4100-8 4100-8-XE 4100-8B 4100-8B-XE 6198 9660-XE
About this record
Access comprehensive regulatory information for Lexion Medical AP 50/30 HIGH FLOW INSUFFLATOR in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508318 and owned by Lexion Medical, LLC. The device was registered on July 21, 2023.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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