Taiwan FDA registration 8ae2f0c85065f25b8a76bf5d361aec14
“BIOTRONIK” Dynetic 35 Peripheral Balloon Expandable Stent System
TW: “百多力”黛納緹35周邊球囊擴張支架系統
Taiwan·Risk Class 2·MD·BIOTRONIK AG·Registered May 17, 2021 – May 17, 2026ExpiredRegistration details
- Analysis ID
- 8ae2f0c85065f25b8a76bf5d361aec14
- License Form
- Ministry of Health Medical Device Import No. 034529
- Customs Code
- DHA05603452909
Company information
- Manufacturer
- BIOTRONIK AG
- Manufacturer Country
- Switzerland
- Authorized Representative
- BIOTRONIK TAIWAN LIMITED
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- E Cardiovascular devices
- Product Type (Level 2)
- E0001 Cardiovascular stents
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- May 17, 2021
- Expiry Date
- May 17, 2026
About this record
Access comprehensive regulatory information for “BIOTRONIK” Dynetic 35 Peripheral Balloon Expandable Stent System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8ae2f0c85065f25b8a76bf5d361aec14 and manufactured by BIOTRONIK AG. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.
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.
Free DatabasePowered by Pure Global AI89,000+ Devices