Taiwan FDA registration 68e1c4ca488b3545b1194e9686aa6946

Mingjie 10-item urine test strips

TW: 明傑十項尿液試紙

Taiwan·Risk Class 2·Mingjie Enterprise Co., Ltd.;; Dongyao Biotechnology Co., Ltd·Registered Jun 28, 2023 – Sep 22, 2025Expired

Registration details

Analysis ID: 68e1c4ca488b3545b1194e9686aa6946

Company information

Manufacturer: Mingjie Enterprise Co., Ltd.;; Dongyao Biotechnology Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: MIN JIER FIRM

Product details

Intended Use: It can detect white blood cells (Leukocytes), nitrite (Nitrite), urobilinogen (Uro-bilinogen), protein (Protein), pH (pH), occult blood (Occult blood), specific gravity (Specific gravity), ketone (Ketone), bilirubin (Bilirubin) and glucose (Glucose) in the urine.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1115 Urine bilirubin and its conjugates (non-quantitative) test system;; A.1340 Urine glucose (non-quantitative) test system;; A.1550 Uric pH (non-quantitative) testing system
Import Information: 委託製造;; QMS/QSD;; 國產

Dates and status

Registration Date: Jun 28, 2023
Expiry Date: Sep 22, 2025

About this record

Access comprehensive regulatory information for Mingjie 10-item urine test strips in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 68e1c4ca488b3545b1194e9686aa6946 and manufactured by Mingjie Enterprise Co., Ltd.;; Dongyao Biotechnology Co., Ltd. The authorized representative in Taiwan is MIN JIER FIRM.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.