Taiwan FDA registration fe18fc776cab428ea7d3e0c96f880f56
"Kabi" Ambiex Implantable Injection System Attachment
TW: “卡比” 安比適植入型注射系統附件
Taiwan·Risk Class 2·PHS Medical GmbH;; Fresenius Kabi AG·Registered May 17, 2021 – May 17, 2026ExpiredRegistration details
- Analysis ID
- fe18fc776cab428ea7d3e0c96f880f56
- Customs Code
- DHA05603453007
Company information
- Manufacturer
- PHS Medical GmbH;; Fresenius Kabi AG
- Manufacturer Country
- Germany
- Authorized Representative
- FRESENIUS KABI TAIWAN LIMITED
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- J General hospital and personal use equipment
- Product Type (Level 2)
- J.5965 Subcutaneous implantable intravascular injection port and guide
- Import Information
- Input;; Contract manufacturing
Dates and status
- Registration Date
- May 17, 2021
- Expiry Date
- May 17, 2026
About this record
Access comprehensive regulatory information for "Kabi" Ambiex Implantable Injection System Attachment in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number fe18fc776cab428ea7d3e0c96f880f56 and manufactured by PHS Medical GmbH;; Fresenius Kabi AG. The authorized representative in Taiwan is FRESENIUS KABI TAIWAN LIMITED.
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