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Disposable medical suture machine

์ผํšŒ์šฉ์˜๋ฃŒ์šฉ๋ด‰ํ•ฉ๊ธฐ

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 No. 22-4415. Approved on Aug 23, 2022. Registered by Smith & Nepew, Inc..

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MFDS Official Data
Class II
Basic Information
Item Serial Number
2022004306
License Number
Suin No. 22-4415
์ˆ˜์ธ22-4415ํ˜ธ
Classification Number
A38010.02(2)
Device Class (Risk Classification)
Class II
Classification Name
Disposable medical suture machine
์ผํšŒ์šฉ์˜๋ฃŒ์šฉ๋ด‰ํ•ฉ๊ธฐ
Official English Name
Suture instrument, single-use
Company Information
Entity Name (Company)
Smith & Nepew, Inc.
์Šค๋ฏธ์Šค์•ค๋“œ๋„คํ“จ(์ฃผ)
Entity Address
์„œ์šธํŠน๋ณ„์‹œ ๊ฐ•๋‚จ๊ตฌ ์˜๋™๋Œ€๋กœ 517 , 13์ธต ์ผ๋ถ€(์‚ผ์„ฑ๋™, ์•„์…ˆํƒ€์›Œ)
Manufacturer
Smith & Nephew Inc.,ArthroCare Corporation
Category
Import business
์ˆ˜์ž…์—…
Business License Number
์ œ 360 ํ˜ธ
Important Dates & Status
Item Approval Date
Aug 23, 2022
Business Permit Date
Mar 24, 2005
Expiration Period
2022-08-23 ~ 2027-08-22
For Export
์•„๋‹ˆ์˜ค
Model Information
Model Name
7209485
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