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Class 1 Medical Image Transmission Device Software

1๋“ฑ๊ธ‰์˜๋ฃŒ์˜์ƒ์ „์†ก์žฅ์น˜์†Œํ”„ํŠธ์›จ์–ด

This Class I medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / ์‹ํ’ˆ์˜์•ฝํ’ˆ์•ˆ์ „์ฒ˜) under license number Reception No. 21-1874. Approved on Oct 14, 2021. Registered by Oriental Medical Equipment Co., Ltd..

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MFDS Official Data
Class I
Basic Information
Item Serial Number
2021005557
License Number
Reception No. 21-1874
์ˆ˜์‹ 21-1874ํ˜ธ
Classification Number
E11010.02(1)
Device Class (Risk Classification)
Class I
Classification Name
Class 1 Medical Image Transmission Device Software
1๋“ฑ๊ธ‰์˜๋ฃŒ์˜์ƒ์ „์†ก์žฅ์น˜์†Œํ”„ํŠธ์›จ์–ด
Official English Name
Medical image, picture archiving and communication system, software class 1
Company Information
Entity Name (Company)
Oriental Medical Equipment Co., Ltd.
๋™๋ฐฉ์˜๋ฃŒ๊ธฐ(์ฃผ)
Entity Address
์„œ์šธํŠน๋ณ„์‹œ ๊ฐ•๋‚จ๊ตฌ ์„ ๋ฆ‰๋กœ100๊ธธ 30 3์ธต์ผ๋ถ€ (์‚ผ์„ฑ๋™,์œ ๋‹ˆ์ฝ˜๋นŒ๋”ฉ)
Manufacturer
Welch Allyn, Inc.
Category
Import business
์ˆ˜์ž…์—…
Business License Number
์ œ 8 ํ˜ธ
Important Dates & Status
Item Approval Date
Oct 14, 2021
Business Permit Date
Jul 27, 2004
Expiration Period
2021-10-14 ~ 2026-10-13
For Export
์•„๋‹ˆ์˜ค
Model Information
Model Name
iExaminer Pro
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DJ Fang

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