Taiwan FDA registration 03d70dae5e4ef30c9d152ac587adc151

"Abbott" automated slide staining machine (unsterilized)

TW: "亞培"自動玻片染色機(未滅菌)

Taiwan·Risk Class 1·SANMINA-SCI SYSTEMS SINGAPORE PTE LTD·Registered Nov 14, 2017 – Nov 14, 2027Active

Registration details

Analysis ID: 03d70dae5e4ef30c9d152ac587adc151
Customs Code: DHA09401850204

Company information

Manufacturer: SANMINA-SCI SYSTEMS SINGAPORE PTE LTD
Manufacturer Country: Singapore
Authorized Representative: ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)

Product details

Intended Use: Limited to the first level identification range of the "Automatic Slide Spinner (B.5850)" of the Measures for the Classification and Grading Management of Medical Devices.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.5850 Automated Slide Rotator
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Nov 14, 2017
Expiry Date: Nov 14, 2027

About this record

Access comprehensive regulatory information for "Abbott" automated slide staining machine (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 03d70dae5e4ef30c9d152ac587adc151 and manufactured by SANMINA-SCI SYSTEMS SINGAPORE PTE LTD. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

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