Taiwan FDA registration 513d0d87cdb4ff9c6fc56b80c847b3a6
"PrimeMed" Orthopedic manual surgical instrument (Non-Sterile)
TW: "首要醫學" 手動式骨科手術器械 (未滅菌)
Taiwan·Risk Class 1·MD·PRIMEMED, INC·Registered Aug 16, 2017 – Aug 16, 2022ExpiredRegistration details
- Analysis ID
- 513d0d87cdb4ff9c6fc56b80c847b3a6
- License Form
- Ministry of Health Medical Device Import No. 018195
- Customs Code
- DHA09401819508
Company information
- Manufacturer
- PRIMEMED, INC
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- Chentian Enterprises Co., Ltd
Product details
- Intended Use
- Limited to the first level identification range of manual orthopedic surgical instruments (N.4540) of the Measures for the Administration of Medical Equipment.
- Product Type (Level 1)
- N Orthopedic devices
- Product Type (Level 2)
- N4540 Manual osteologic surgery instrument
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Aug 16, 2017
- Expiry Date
- Aug 16, 2022
About this record
Access comprehensive regulatory information for "PrimeMed" Orthopedic manual surgical instrument (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 513d0d87cdb4ff9c6fc56b80c847b3a6 and manufactured by PRIMEMED, INC. The authorized representative in Taiwan is Chentian Enterprises Co., Ltd.
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