Taiwan FDA registration 639a82f197f8dfd104f532b7de82aa3c
"Elekoda" radiotherapy system
TW: “醫科達”放射治療系統
Taiwan·Risk Class 2·Elekta Solutions AB;; Elekta Limited·Registered Jun 20, 2019 – Jun 20, 2029ActiveRegistration details
- Analysis ID
- 639a82f197f8dfd104f532b7de82aa3c
- Customs Code
- DHAS5603264407
Company information
- Manufacturer
- Elekta Solutions AB;; Elekta Limited
- Manufacturer Country
- United Kingdom;;Sweden
- Authorized Representative
- CHIU HO MEDICAL SYSTEM CO., LTD.
Product details
- Intended Use
- For details, it is Chinese approved copy of the imitation order
- Product Type (Level 1)
- P Radiology Science
- Product Type (Level 2)
- P.5050 Medical Charged Particle Radiotherapy System
- Import Information
- Consent must be attached to the import (with the consent of the Atomic Energy Commission must be obtained for each import); The use of this device shall comply with the provisions of the "Administrative Measures for the Implementation or Use of Medical Devices for Specific Medical Technology Inspection and Testing". input
Dates and status
- Registration Date
- Jun 20, 2019
- Expiry Date
- Jun 20, 2029
About this record
Access comprehensive regulatory information for "Elekoda" radiotherapy system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 639a82f197f8dfd104f532b7de82aa3c and manufactured by Elekta Solutions AB;; Elekta Limited. The authorized representative in Taiwan is CHIU HO MEDICAL SYSTEM CO., LTD..
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