Taiwan FDA registration 9fed9988a7097039488c297f45790444
Arcadia Steerable Balloon and Straight Balloon Catheter
TW: 阿卡迪亞可控球囊和直球囊導管
Taiwan·Risk Class 2·MD·Merit Medical Systems, Inc.·Registered Sep 20, 2023 – Sep 20, 2028ActiveRegistration details
- Analysis ID
- 9fed9988a7097039488c297f45790444
- License Form
- Ministry of Health Medical Device Import No. 036734
- Customs Code
- DHA05603673407
Company information
- Manufacturer
- Merit Medical Systems, Inc.
- Manufacturer Country
- United States
- Authorized Representative
- Merit Medical Asia Company Limited Taiwan Branch (Hong Kong)
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- N Orthopedics
- Product Type (Level 2)
- N0004 Bone Dilation Molding System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Sep 20, 2023
- Expiry Date
- Sep 20, 2028
About this record
Access comprehensive regulatory information for Arcadia Steerable Balloon and Straight Balloon Catheter in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9fed9988a7097039488c297f45790444 and manufactured by Merit Medical Systems, Inc.. The authorized representative in Taiwan is Merit Medical Asia Company Limited Taiwan Branch (Hong Kong).
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
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