Taiwan FDA registration 857c38bd66c9d77349a8edd068440a5e

Roche Blood Collection Pen (unsterilized)

TW: 羅氏舒柔採血筆(未滅菌)

Taiwan·Risk Class 1·Roche Diabetes Care GmbH;; Balda Medical GmbH·Registered Aug 30, 2022 – Aug 30, 2027Active

Registration details

Analysis ID: 857c38bd66c9d77349a8edd068440a5e
Customs Code: DHA09402288407

Company information

Manufacturer: Roche Diabetes Care GmbH;; Balda Medical GmbH
Manufacturer Country: Germany
Authorized Representative: ROCHE DIAGNOSTICS LTD.

Product details

Intended Use: Limited to the first level identification scope of the "Manual Instruments for General Surgery (I.4800)" of the Measures for the Classification and Grading Management of Medical Equipment.
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4800 Hand Instruments for General Surgery
Import Information: 輸入;; QMS/QSD;; 委託製造

Dates and status

Registration Date: Aug 30, 2022
Expiry Date: Aug 30, 2027

About this record

Access comprehensive regulatory information for Roche Blood Collection Pen (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 857c38bd66c9d77349a8edd068440a5e and manufactured by Roche Diabetes Care GmbH;; Balda Medical GmbH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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