Taiwan FDA registration 211049d1956f61f926026642f2f7fcb7
Scouton safe automatic insulin pen with needle
TW: 秀康福安全型自動胰島素筆配用針
Taiwan·Risk Class 2·MedExel Co., Ltd.; Allison Medical Inc.·Registered Mar 19, 2023 – Mar 19, 2028ActiveRegistration details
- Analysis ID
- 211049d1956f61f926026642f2f7fcb7
- Customs Code
- DHA05603633101
Company information
- Manufacturer
- MedExel Co., Ltd.; Allison Medical Inc.
- Manufacturer Country
- Korea, Republic of;;United States
- Authorized Representative
- ACE TW KY Co., 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)
- J.5570 Subcutaneous single-chamber needle
- Import Information
- Contract manufacturing;; input
Dates and status
- Registration Date
- Mar 19, 2023
- Expiry Date
- Mar 19, 2028
About this record
Access comprehensive regulatory information for Scouton safe automatic insulin pen with needle in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 211049d1956f61f926026642f2f7fcb7 and manufactured by MedExel Co., Ltd.; Allison Medical Inc.. The authorized representative in Taiwan is ACE TW KY Co., Ltd..
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