Taiwan FDA registration b750d2420d2c3db0ac3e11dacc373180
"Wingtech Baltur" manual orthopedic surgical instruments (unsterilized)
TW: "聞泰百得"手動式骨科手術器械(未滅菌)
Taiwan·Risk Class 1·Wuxi BoTEC Medical Innovation Co., Ltd·Registered Dec 07, 2022 – Dec 07, 2027ActiveRegistration details
- Analysis ID
- b750d2420d2c3db0ac3e11dacc373180
- Customs Code
- DHA09600470702
Company information
- Manufacturer
- Wuxi BoTEC Medical Innovation Co., Ltd
- Manufacturer Country
- China
- Authorized Representative
- A-SPINE Asia Co., Ltd.
Product details
- Intended Use
- Limited to the classification and grading management measures of medical equipment "Manual orthopedic surgical instruments (N.4540)" first grade identification range.
- Product Type (Level 1)
- N Orthopedics
- Product Type (Level 2)
- N.4540 手動式骨科手術器械
- Import Information
- QMS/QSD;; Input;; Chinese goods
Dates and status
- Registration Date
- Dec 07, 2022
- Expiry Date
- Dec 07, 2027
About this record
Access comprehensive regulatory information for "Wingtech Baltur" manual orthopedic surgical instruments (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b750d2420d2c3db0ac3e11dacc373180 and manufactured by Wuxi BoTEC Medical Innovation Co., Ltd. The authorized representative in Taiwan is A-SPINE Asia Co., Ltd..
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