Taiwan FDA registration b09c01d3a26fcce762440d8451055699
Roche albumin urine test strip (unsterilized)
TW: 羅氏白蛋白尿液檢驗試紙 (未滅菌)
Taiwan·Risk Class 1·ROCHE DIAGNOSTICS GMBH·Registered Feb 14, 2023 – Feb 14, 2028ActiveRegistration details
- Analysis ID
- b09c01d3a26fcce762440d8451055699
- Customs Code
- DHA09402304509
Company information
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- ROCHE DIAGNOSTICS 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
- Feb 14, 2023
- Expiry Date
- Feb 14, 2028
About this record
Access comprehensive regulatory information for Roche albumin urine test strip (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b09c01d3a26fcce762440d8451055699 and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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