Taiwan FDA registration 1db359bb34db8f6dedfbbcaa05117d63
Shimadzu Manufacturing Diagnostic X-ray tube sleeve assembly (unsterilized)
TW: "島津製作所" 診斷用X光球管套組件(未滅菌)
Registration details
- Analysis ID
- 1db359bb34db8f6dedfbbcaa05117d63
- Customs Code
- DHAS9402302001
Company information
- Manufacturer
- SHIMADZU CORPORATION, SANJO FACTORY
- Manufacturer Country
- Japan
- Authorized Representative
- SAN KANG INSTRUMENTS CO., LTD.
Product details
- Intended Use
- Limited to the first level identification range of the "X-ray tube sleeve assembly for diagnosis (P.1760)" of the Measures for the Classification and Grading Management of Medical Equipment.
- Product Type (Level 1)
- P Radiology Science
- Product Type (Level 2)
- P.1760 診斷用X光球管套組件
- Import Information
- Consent must be attached to the import (with the consent of the Atomic Energy Commission must be obtained for each import); Input;; QMS/QSD
Dates and status
- Registration Date
- Jan 18, 2023
- Expiry Date
- Jan 18, 2028
About this record
Access comprehensive regulatory information for Shimadzu Manufacturing Diagnostic X-ray tube sleeve assembly (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 1db359bb34db8f6dedfbbcaa05117d63 and manufactured by SHIMADZU CORPORATION, SANJO FACTORY. The authorized representative in Taiwan is SAN KANG INSTRUMENTS CO., LTD..
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