Vietnam MOH registration 240000029/PCBB-HCM

Temperature-sensing Foley catheter

VN: Ống thông tiểu có cảm biến nhiệt độ

Vietnam·Risk Class TTBYT Loại B·Silicone Foley Catheter With Temperature Sensor·Guangdong Ecan Medical Co., Ltd·Registered Jan 02, 2024

Registration details

Analysis ID: 240000029/PCBB-HCM
Submission ID: 000.00.19.H29-231223-0008
Product Type: Silicone Foley Catheter With Temperature Sensor
Product Code: EC020608ST; EC020610ST; EC020612ST; EC020614ST; ECO20616ST; EC020618ST ; EC020620ST ; EC020622ST ; EC020624ST; EC020626ST; EC020628ST; EC020630ST

Company information

Manufacturer: Guangdong Ecan Medical Co., Ltd
Product Owner: ECAN MEDICAL CO., LTD
Authorized Representative: CÔNG TY CỔ PHẦN THƯƠNG MẠI CÔNG NGHỆ TÂM Y

Technical details

Intended Use: The temperature-sensing catheter is introduced through the urethra during the process of placing the catheter into the bladder to drain urine. The temperature sensor can be used to monitor the bladder temperature during the drainage process to support clinical diagnosis. It is used to monitor the temperature in patients who are placed with a catheter due to fluid regulation issues, to assess urine volume, and the filtration of urine after surgery or trauma involving the pelvic organs, or in cases of obstruction and paralysis.

Dates and status

Registration Date: Jan 02, 2024

About this record

Access comprehensive regulatory information for Temperature-sensing Foley catheter in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000029/PCBB-HCM and manufactured by Guangdong Ecan Medical Co., Ltd. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THƯƠNG MẠI CÔNG NGHỆ TÂM Y.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.