Taiwan FDA registration 6980ce231b1af25f09c37d6ed9884faf

"Wright" Unoller urine dynamic measurement system and accessories (unsterilized)

TW: “萊特” 優諾勒尿液動力測量系統及配件（未滅菌）

Taiwan·Risk Class 1·LIFE-TECH, INC.·Registered Dec 14, 2005 – Dec 14, 2015Cancelled

Registration details

Analysis ID: 6980ce231b1af25f09c37d6ed9884faf
Customs Code: DHA04400225803

Company information

Manufacturer: LIFE-TECH, INC.
Manufacturer Country: United States
Authorized Representative: Cihai Industrial Co., Ltd

Product details

Intended Use: A device used to measure the capacity and pressure of the bladder when the catheter is filled with carbon dioxide or water. The device controls the supply of carbon dioxide or water and also records the electrical current in the muscles during urination. The equipment includes a transmitter, telecommunication conditioning and display, a catheter retraction device to obtain the status of urethral pressure, a special catheter for urinary catheter shape determination, and electrodes for electromyography. The general types of this equipment include bladder gas (carbon dioxide) manometer, bladder hydraulic manometer, bladder volume pressure electric recorder, but not any device that fills the bladder with air.
Product Type (Level 1): H Gastroenterology and urology
Product Type (Level 2): H.1620 尿液動力測量系統
Import Information: import

Dates and status

Registration Date: Dec 14, 2005
Expiry Date: Dec 14, 2015
Cancellation Date: Jan 29, 2016

Cancellation information

Status: Logged out
Reason: 公司歇業

About this record

Access comprehensive regulatory information for "Wright" Unoller urine dynamic measurement system and accessories (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 6980ce231b1af25f09c37d6ed9884faf and manufactured by LIFE-TECH, INC.. The authorized representative in Taiwan is Cihai Industrial Co., Ltd.

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