Taiwan FDA registration 09266ce67efb4e8ad3ce34cc61178208
“BIOTRONIK”LI plus G Tearaway Sheath Introducer Kit
TW: “百多力”剝離式鞘管導引裝置組
Taiwan·Risk Class 2·MD·Galt Medical Corp.·Registered Mar 21, 2023 – Mar 21, 2028ActiveRegistration details
- Analysis ID
- 09266ce67efb4e8ad3ce34cc61178208
- License Form
- Ministry of Health Medical Device Import No. 036332
- Customs Code
- DHA05603633200
Company information
- Manufacturer
- Galt Medical Corp.
- Manufacturer Country
- United States
- 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)
- E1340 Catheter Guide
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Mar 21, 2023
- Expiry Date
- Mar 21, 2028
About this record
Access comprehensive regulatory information for “BIOTRONIK”LI plus G Tearaway Sheath Introducer Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 09266ce67efb4e8ad3ce34cc61178208 and manufactured by Galt Medical Corp.. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.
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