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Passive brachytherapy irradiation device

์ˆ˜๋™์‹๊ทผ์ ‘์น˜๋ฃŒ์šฉ๋ฐฉ์‚ฌ์„ ์กฐ์‚ฌ์žฅ์น˜

This Unknown medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / ์‹ํ’ˆ์˜์•ฝํ’ˆ์•ˆ์ „์ฒ˜) under license number Suhe 23-234. Approved on Jun 09, 2023. Registered by Boston Scientific Korea Co., Ltd..

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MFDS Official Data
Unknown
Basic Information
Item Serial Number
2021005768
License Number
Suhe 23-234
์ˆ˜ํ—ˆ23-234ํ˜ธ
Classification Number
A13080.01
Device Class (Risk Classification)
Unknown
Classification Name
Manual brachytherapy irradiation device
์ˆ˜๋™์‹ ๊ทผ์ ‘์น˜๋ฃŒ์šฉ ๋ฐฉ์‚ฌ์„  ์กฐ์‚ฌ์žฅ์น˜
Official English Name
Radiation interstitial therapy, manually-operated
Company Information
Entity Name (Company)
Boston Scientific Korea Co., Ltd.
๋ณด์Šคํ†ค์‚ฌ์ด์–ธํ‹ฐํ”ฝ์ฝ”๋ฆฌ์•„(์ฃผ)
Category
Import business
์ˆ˜์ž…์—…
Business License Number
์ œ 384 ํ˜ธ
Important Dates & Status
Item Approval Date
Jun 09, 2023
Business Permit Date
Apr 01, 2005
Expiration Period
2023-06-09 ~ 2028-06-08
Model Information
Model Name
TheraSphere
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DJ Fang

DJ Fang

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