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Electrocorporeal shock fracture crusher

์ „๊ธฐ์ฒด์™ธ์ถฉ๊ฒฉํŒŒ์‡„์„๊ธฐ

This Class III medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / ์‹ํ’ˆ์˜์•ฝํ’ˆ์•ˆ์ „์ฒ˜) under license number Suhe 21-309. Approved on Dec 15, 2021. Registered by Dong Aesti Co., Ltd..

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MFDS Official Data
Class III
Basic Information
Item Serial Number
2021006671
License Number
Suhe 21-309
์ˆ˜ํ—ˆ21-309ํ˜ธ
Classification Number
A18010.02(3)
Device Class (Risk Classification)
Class III
Classification Name
Electrocorporeal shock fracture crusher
์ „๊ธฐ์ฒด์™ธ์ถฉ๊ฒฉํŒŒ์‡„์„๊ธฐ
Official English Name
Lithotriptor, external, electromechanical
Company Information
Entity Name (Company)
Dong Aesti Co., Ltd.
๋™์•„์—์Šคํ‹ฐ(์ฃผ)
Entity Address
์„œ์šธํŠน๋ณ„์‹œ ๋™๋Œ€๋ฌธ๊ตฌ ์ฒœํ˜ธ๋Œ€๋กœ 64 (์šฉ๋‘๋™)
Manufacturer
Storz Medical AG
Category
Import business
์ˆ˜์ž…์—…
Business License Number
์ œ 561 ํ˜ธ
Important Dates & Status
Item Approval Date
Dec 15, 2021
Business Permit Date
May 16, 2005
Expiration Period
2021-12-15 ~ 2026-12-14
For Export
์•„๋‹ˆ์˜ค
Model Information
Model Name
Modulith SLK(0L)
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