Taiwan FDA registration f21825c26f5d1d43c90f12e0c5ce0f0f
"Boltai" II polyetheretherketone lumbar intervertebral fusion device
TW: “博爾泰”II聚醚醚酮腰椎椎間融合器
Taiwan·Risk Class 2·A-SPINE Asia Co., Ltd.·Registered Dec 19, 2016 – Dec 05, 2018CancelledRegistration details
- Analysis ID
- f21825c26f5d1d43c90f12e0c5ce0f0f
Company information
- Manufacturer
- A-SPINE Asia Co., Ltd.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Boltai GmbH
Product details
- Intended Use
- For details, it is Chinese approved copy of the imitation order
- Product Type (Level 1)
- N Orthopedics
- Product Type (Level 2)
- N.3060 椎體間之脊椎矯正固定物
- Import Information
- Domestic;; Contract manufacturing
Dates and status
- Registration Date
- Dec 19, 2016
- Expiry Date
- Dec 05, 2018
- Cancellation Date
- May 19, 2022
Cancellation information
- Status
- Logged out
- Reason
- 自行鍵入
About this record
Access comprehensive regulatory information for "Boltai" II polyetheretherketone lumbar intervertebral fusion device in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f21825c26f5d1d43c90f12e0c5ce0f0f and manufactured by A-SPINE Asia Co., Ltd.. The authorized representative in Taiwan is Boltai GmbH.
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