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Electrodes for disposable foot control electrosurgical devices

์ผํšŒ์šฉ๋ฐœ์กฐ์ ˆ์‹์ „๊ธฐ์ˆ˜์ˆ ๊ธฐ์šฉ์ „๊ทน

This Class II medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / ์‹ํ’ˆ์˜์•ฝํ’ˆ์•ˆ์ „์ฒ˜) under license number Suin 22-4508. Approved on Oct 28, 2022. Registered by Boston Scientific Korea Co., Ltd..

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MFDS Official Data
Class II
Basic Information
Item Serial Number
2022003490
License Number
Suin 22-4508
์ˆ˜์ธ22-4508ํ˜ธ
Classification Number
A35025.03(2)
Device Class (Risk Classification)
Class II
Classification Name
Electrodes for disposable foot control electrosurgical devices
์ผํšŒ์šฉ๋ฐœ์กฐ์ ˆ์‹์ „๊ธฐ์ˆ˜์ˆ ๊ธฐ์šฉ์ „๊ทน
Official English Name
Electrosurgical system electrode, foot-controlled, single-use
Company Information
Entity Name (Company)
Boston Scientific Korea Co., Ltd.
๋ณด์Šคํ†ค์‚ฌ์ด์–ธํ‹ฐํ”ฝ์ฝ”๋ฆฌ์•„(์ฃผ)
Entity Address
์„œ์šธํŠน๋ณ„์‹œ ๊ฐ•๋‚จ๊ตฌ ์–ธ์ฃผ๋กœ30๊ธธ 39 19์ธต(๋„๊ณก๋™,์—์Šค์ด์•„์ดํƒ€์›Œ)
Manufacturer
STATICE Manufacturing
Category
Import business
์ˆ˜์ž…์—…
Business License Number
์ œ 384 ํ˜ธ
Important Dates & Status
Item Approval Date
Oct 28, 2022
Business Permit Date
Apr 01, 2005
Expiration Period
2022-10-28 ~ 2027-10-27
For Export
์•„๋‹ˆ์˜ค
Model Information
Model Name
M00500070
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DJ Fang

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