Pure Global

Abbott Korea Diagnostics

(์ฃผ)ํ•œ๊ตญ์• ๋ณดํŠธ์ง„๋‹จ

Complete regulatory portfolio for Abbott Korea Diagnostics in South Korea's medical device market. This company has 270 medical devices registered with South Korea MFDS, with registrations dating from Feb 05, 2014 to Oct 31, 2023.

Browse the complete device portfolio including device classifications, license numbers, approval dates, and technical specifications. Pure Global AI provides free access to comprehensive South Korea MFDS registration data, helping global MedTech companies analyze market presence and regulatory compliance for medical device manufacturers in South Korea.

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MFDS Official Data
270 Devices
Company Overview
Total Devices
270
Address
๊ฒฝ๊ธฐ๋„ ์šฉ์ธ์‹œ ๊ธฐํฅ๊ตฌ ํ•˜๊ฐˆ๋กœ15๋ฒˆ๊ธธ 46 (๋ณด๋ผ๋™)
Registration Timeline
Earliest Approval
Feb 05, 2014
Latest Approval
Oct 31, 2023
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Device Class Distribution
Breakdown of 270 devices by regulatory classification
Unknown
224
83.0% of total
Class III
20
7.4% of total
Class II
15
5.6% of total
Class I
10
3.7% of total
Class IV
1
0.4% of total
Registered Devices (10 most recent shown)
Click on any device for detailed registration information
Device NameClassLicense NumberApproval DateDetail
High-risk infection immunoassay reagent
๊ณ ์œ„ํ—˜์„ฑ๊ฐ์—ผ์ฒด๋ฉด์—ญ๊ฒ€์‚ฌ์‹œ์•ฝ
Unknown
In Vitro Drug No. 23-1018
Oct 31, 2023
High-risk infection immunoassay reagent
๊ณ ์œ„ํ—˜์„ฑ๊ฐ์—ผ์ฒด๋ฉด์—ญ๊ฒ€์‚ฌ์‹œ์•ฝ
Unknown
In Vitro No. 23-906
Sep 11, 2023
Disposable Automatic Lancet
์ผํšŒ์šฉ์ž๋™๋žœ์‹ฏ
Unknown
Suin 23-4614
Jun 07, 2023
Disposable manual lancet
์ผํšŒ์šฉ์ˆ˜๋™๋žœ์‹ฏ
Unknown
Suin 23-4616
Jun 07, 2023
Capillary blood collection tube
๋ชจ์„ธ๊ด€์ฑ„ํ˜ˆํŠœ๋ธŒ
Unknown
Reception No. 23-494
Mar 08, 2023
High-risk infection immunoassay reagent
๊ณ ์œ„ํ—˜์„ฑ๊ฐ์—ผ์ฒด๋ฉด์—ญ๊ฒ€์‚ฌ์‹œ์•ฝ
Class III
In Vitro Formulation No. 23-39
Jan 18, 2023
Infectious agent diagnostic immunoassay reagent
๊ฐ์—ผ์ฒด ์ง„๋‹จ ๋ฉด์—ญ๊ฒ€์‚ฌ์‹œ์•ฝ
Unknown
In Vitro No. 22-507
Jul 29, 2022
High-risk infection immunoassay reagent
๊ณ ์œ„ํ—˜์„ฑ๊ฐ์—ผ์ฒด๋ฉด์—ญ๊ฒ€์‚ฌ์‹œ์•ฝ
Unknown
In Vitro No. 22-291
May 06, 2022
High-risk infection immunoassay reagent
๊ณ ์œ„ํ—˜์„ฑ๊ฐ์—ผ์ฒด๋ฉด์—ญ๊ฒ€์‚ฌ์‹œ์•ฝ
Unknown
In Vitro No. 22-114
Feb 18, 2022
High-risk infection immunoassay reagent
๊ณ ์œ„ํ—˜์„ฑ๊ฐ์—ผ์ฒด๋ฉด์—ญ๊ฒ€์‚ฌ์‹œ์•ฝ
Unknown
In Vitro No. 22-4
Jan 06, 2022