Taiwan FDA registration 65bdcd5307dcb9b45db88e30203f349e
“BIOTRONIK” Khelix Loop Electrophysiology Catheter incl. Accessories
TW: “百多力” 赫里斯環圈電生理導管(包括配件)
Taiwan·Risk Class 2·MD·CathRx Ltd·Registered Sep 13, 2023 – Sep 13, 2028ActiveRegistration details
- Analysis ID
- 65bdcd5307dcb9b45db88e30203f349e
- License Form
- Ministry of Health Medical Device Import No. 036604
- Customs Code
- DHA05603660407
Company information
- Manufacturer
- CathRx Ltd
- Manufacturer Country
- Australia
- Authorized Representative
- BIOTRONIK TAIWAN LIMITED
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- E Cardiovascular Medicine Science
- Product Type (Level 2)
- E1220 electrode recording catheter or electrode recording probe
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Sep 13, 2023
- Expiry Date
- Sep 13, 2028
About this record
Access comprehensive regulatory information for “BIOTRONIK” Khelix Loop Electrophysiology Catheter incl. Accessories in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 65bdcd5307dcb9b45db88e30203f349e and manufactured by CathRx Ltd. 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