Taiwan FDA registration 6bd9bbaee8e243af640b879cc5f6c88e
“BIOTRONIK” Passeo-35, PTA balloon catheter
TW: “百多力”帕希爾35周邊血管氣球擴張導管
Taiwan·Risk Class 2·MD·BIOTRONIK AG·Registered May 09, 2014 – May 09, 2024ExpiredRegistration details
- Analysis ID
- 6bd9bbaee8e243af640b879cc5f6c88e
- License Form
- Ministry of Health Medical Device Import No. 026142
- Customs Code
- DHA05602614202
Company information
- Manufacturer
- BIOTRONIK AG
- Manufacturer Country
- Switzerland
- Authorized Representative
- BIOTRONIK TAIWAN LIMITED
Product details
- Intended Use
- For details, it is Chinese approved copy of the imitation order
- Product Type (Level 1)
- E Cardiovascular devices
- Product Type (Level 2)
- E1250 Percutaneous catheter
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- May 09, 2014
- Expiry Date
- May 09, 2024
About this record
Access comprehensive regulatory information for “BIOTRONIK” Passeo-35, PTA 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 6bd9bbaee8e243af640b879cc5f6c88e 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