Taiwan FDA registration 7efa02e27f7085bcf3632f9e3c348005
"KometaBio" Orthopedic manual surgical instrument (Non-Sterile)
TW: "冠京" 手動式骨科手術器械 (未滅菌)
Taiwan·Risk Class 1·MD·KOMETABIO INC.·Registered Sep 06, 2019 – Sep 06, 2024ExpiredRegistration details
- Analysis ID
- 7efa02e27f7085bcf3632f9e3c348005
- License Form
- Ministry of Health Medical Device Import No. 020839
- Customs Code
- DHA09402083905
Company information
- Manufacturer
- KOMETABIO INC.
- Manufacturer Country
- United States
- Authorized Representative
- SMART-LINKX BIOTECH 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
- Sep 06, 2019
- Expiry Date
- Sep 06, 2024
About this record
Access comprehensive regulatory information for "KometaBio" 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 7efa02e27f7085bcf3632f9e3c348005 and manufactured by KOMETABIO INC.. The authorized representative in Taiwan is SMART-LINKX BIOTECH CO., LTD..
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