Taiwan FDA registration 659ea721df45656c63284ff3aa30e2a7
"Pelspeye" Disposable Percutaneous Minimally Invasive Lateral Intervertebral Foramen Surgical Kit (Sterilized)
TW: "派爾史派" 一次性經皮微創外側椎間孔洞手術套組 (滅菌)
Taiwan·Risk Class 1·BIOSPINE CO., LTD·Registered Jun 14, 2017 – Jun 14, 2022CancelledRegistration details
- Analysis ID
- 659ea721df45656c63284ff3aa30e2a7
- Customs Code
- DHA09401795803
Company information
- Manufacturer
- BIOSPINE CO., LTD
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- BUTICON INTERNATIONAL CORPORATION
Product details
- Intended Use
- Limited to the first level identification scope of the Measures for the Administration of Medical Devices "Non-powered Neurosurgical Devices (K.4535)".
- Product Type (Level 1)
- K Neuroscience
- Product Type (Level 2)
- K.4535 非動力式神經外科用器械
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Jun 14, 2017
- Expiry Date
- Jun 14, 2022
- Cancellation Date
- Apr 12, 2024
Cancellation information
- Status
- Logged out
- Reason
- 許可證已逾有效期
About this record
Access comprehensive regulatory information for "Pelspeye" Disposable Percutaneous Minimally Invasive Lateral Intervertebral Foramen Surgical Kit (Sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 659ea721df45656c63284ff3aa30e2a7 and manufactured by BIOSPINE CO., LTD. The authorized representative in Taiwan is BUTICON INTERNATIONAL CORPORATION.
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