Taiwan FDA registration 369dce879d68ccf33d27d3abca71f859
Accu-Fine Pen Needle
TW: 羅氏怡穩筆型針頭
Taiwan·Risk Class 2·MD·HTL-STREFA S.A.·Registered Sep 07, 2022 – Sep 07, 2027ActiveRegistration details
- Analysis ID
- 369dce879d68ccf33d27d3abca71f859
- License Form
- Ministry of Health Medical Device Import No. 035789
- Customs Code
- DHA05603578901
Company information
- Manufacturer
- HTL-STREFA S.A.
- Manufacturer Country
- Poland
- Authorized Representative
- ROCHE DIAGNOSTICS LTD.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- J General hospital and personal use equipment
- Product Type (Level 2)
- J5570 Subcutaneous single-lumen needle
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Sep 07, 2022
- Expiry Date
- Sep 07, 2027
About this record
Access comprehensive regulatory information for Accu-Fine Pen Needle in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 369dce879d68ccf33d27d3abca71f859 and manufactured by HTL-STREFA S.A.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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