Taiwan FDA registration 95ada6ee9a4431ca52983c80408cc9bf

"Orfa" Ulu Flow Automatic Urine Flow Meter (Unsterilized)

TW: “奧爾發“ 優路流自動式尿流儀(未滅菌)

Taiwan·Risk Class 1·Oruba Technology & Innovation·Registered Aug 07, 2023 – Aug 07, 2028Active

Registration details

Analysis ID: 95ada6ee9a4431ca52983c80408cc9bf
Customs Code: DHA09402320403

Company information

Manufacturer: Oruba Technology & Innovation
Manufacturer Country: Türkiye
Authorized Representative: TAIWAN INSTRUMENT CO., LTD.

Product details

Intended Use: Limited to the first level recognition range of the "Urine Flow or Volume Measurement System (H.1800)" of the Classification and Grading Management Measures for Medical Devices.
Product Type (Level 1): H Gastroenterology and urology
Product Type (Level 2): H.1800 尿液流量或容積測量系統
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Aug 07, 2023
Expiry Date: Aug 07, 2028

About this record

Access comprehensive regulatory information for "Orfa" Ulu Flow Automatic Urine Flow Meter (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 95ada6ee9a4431ca52983c80408cc9bf and manufactured by Oruba Technology & Innovation. The authorized representative in Taiwan is TAIWAN INSTRUMENT CO., LTD..

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