Taiwan FDA registration 7f3d4cbf384e79c2371bc15a39944e6b
"Bortey" polyetheretherketone lumbar intervertebral fusion device
TW: “博爾泰”聚醚醚酮腰椎椎間融合器
Taiwan·Risk Class 2·A-SPINE Asia Co., Ltd.·Registered Dec 22, 2016 – Aug 10, 2020CancelledRegistration details
- Analysis ID
- 7f3d4cbf384e79c2371bc15a39944e6b
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.3080 椎體間融合裝置
- Import Information
- Domestic;; Contract manufacturing
Dates and status
- Registration Date
- Dec 22, 2016
- Expiry Date
- Aug 10, 2020
- Cancellation Date
- May 19, 2022
Cancellation information
- Status
- Logged out
- Reason
- 自行鍵入
About this record
Access comprehensive regulatory information for "Bortey" 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 7f3d4cbf384e79c2371bc15a39944e6b and manufactured by A-SPINE Asia Co., Ltd.. The authorized representative in Taiwan is Boltai GmbH.
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