Taiwan FDA registration 05a682bb5dbf38bc13b8c5ab79329245

"Ojie" microalbumin detection reagent (unsterilized)

TW: "歐捷" 微量白蛋白檢測試劑 (未滅菌)

Taiwan·Risk Class 1·ORGENTEC DIAGNOSTIKA GMBH·Registered Aug 07, 2014 – Aug 07, 2024Expired

Registration details

Analysis ID: 05a682bb5dbf38bc13b8c5ab79329245
Customs Code: DHA09401441900

Company information

Manufacturer: ORGENTEC DIAGNOSTIKA GMBH
Manufacturer Country: Germany
Authorized Representative: IN FUNG CO., LTD.

Product details

Intended Use: Limited to the classification and grading management of medical equipment "albumin immunoassay system (C.5040)" first level recognition range.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.5040 白蛋白免疫試驗系統
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Aug 07, 2014
Expiry Date: Aug 07, 2024

About this record

Access comprehensive regulatory information for "Ojie" microalbumin detection reagent (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 05a682bb5dbf38bc13b8c5ab79329245 and manufactured by ORGENTEC DIAGNOSTIKA GMBH. The authorized representative in Taiwan is IN FUNG CO., LTD..

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