Taiwan FDA registration e6f81b8ecf5739535bea36b78ac364e8

Allium Urethral Stent System

TW: 雅琉恩尿道支架組

Taiwan·Risk Class 2·MD·Allium Ltd.·Registered Dec 05, 2018 – Dec 05, 2028Active

Registration details

Analysis ID: e6f81b8ecf5739535bea36b78ac364e8
License Form: Ministry of Health Medical Device Import No. 031883
Customs Code: DHA05603188302

Company information

Manufacturer: Allium Ltd.
Manufacturer Country: Israel
Authorized Representative: HUILI MEDICAL EQUIPMENT LIMITED

Product details

Intended Use: (i) Allium Triangular Prostatic Urethral Stent (TPS) System: Manages bladder outlet obstruction of the following causes: 1. Enlarged prostate or malignant tumor. 2. After minimally invasive treatment (MIT) of the prostate, causing prostate hot tissue damage. 3. Interstitial radiation therapy (near-stage radiation therapy) after prostate cancer. (ii) Allium Round Posterior Urethral Stent (RPS) System: Manages bladder outlet obstruction of the following causes: 1. After prostate surgery. 2. After total prostatectomy and bladder prostatectomy, the anastomosis of the bladder urethra is narrowed. 3. Posterior urethral stricture. (iii) Allium Bulbar Urethral Stent (BUS) System: Bladder outlet obstruction caused by bulb urethral stricture.
Product Type (Level 1): H Gastroenterology-urology devices
Product Type (Level 2): H4620 Ureteral stents
Import Information: Imported from abroad

Dates and status

Registration Date: Dec 05, 2018
Expiry Date: Dec 05, 2028

About this record

Access comprehensive regulatory information for Allium Urethral Stent System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e6f81b8ecf5739535bea36b78ac364e8 and manufactured by Allium Ltd.. The authorized representative in Taiwan is HUILI MEDICAL EQUIPMENT LIMITED.

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