Taiwan FDA registration 52327c2eea8b26ce0625997230edc629
“BIOTRONIK”SentiCath Ref Introducer Sheath
TW: “百多力”聖凱斯導引鞘
Taiwan·Risk Class 2·MD·ACUTUS MEDICAL, INC·Registered Jun 26, 2022 – Jun 26, 2027ActiveRegistration details
- Analysis ID
- 52327c2eea8b26ce0625997230edc629
- License Form
- Ministry of Health Medical Device Import No. 035512
- Customs Code
- DHA05603551200
Company information
- Manufacturer
- ACUTUS MEDICAL, INC
- 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
- Jun 26, 2022
- Expiry Date
- Jun 26, 2027
About this record
Access comprehensive regulatory information for “BIOTRONIK”SentiCath Ref Introducer Sheath in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 52327c2eea8b26ce0625997230edc629 and manufactured by ACUTUS MEDICAL, INC. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.
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