Taiwan FDA registration ae9a576629f2486046b72f7fda576057
"Irekite" Remote Radiation Therapy Source (Unsterilized)
TW: "衣雷克特" 遠端放射治療射源 (未滅菌)
Taiwan·Risk Class 1·ELEKTA INSTRUMENT AB·Registered Mar 14, 2006 – Mar 14, 2011CancelledRegistration details
- Analysis ID
- ae9a576629f2486046b72f7fda576057
- Customs Code
- DHAS4400291702
Company information
- Manufacturer
- ELEKTA INSTRUMENT AB
- Manufacturer Country
- Sweden
- Authorized Representative
- Qiatai Enterprise Co., Ltd
Product details
- Intended Use
- A radionuclear teletherapy source consists of a radionucleus that is sealed in a container. This device is used in radiotherapy where the radioactive source is placed at a distance from the body.
- Product Type (Level 1)
- P Radiology Science
- Product Type (Level 2)
- P.5740 Radionuclei remote treatment sources
- Import Information
- Consent must be attached to the import (with the consent of the Atomic Energy Commission must be obtained for each import); input
Dates and status
- Registration Date
- Mar 14, 2006
- Expiry Date
- Mar 14, 2011
- Cancellation Date
- Nov 09, 2012
Cancellation information
- Status
- Logged out
- Reason
- 許可證已逾有效期
About this record
Access comprehensive regulatory information for "Irekite" Remote Radiation Therapy Source (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number ae9a576629f2486046b72f7fda576057 and manufactured by ELEKTA INSTRUMENT AB. The authorized representative in Taiwan is Qiatai Enterprise Co., Ltd.
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