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Biorad Korea Co., Ltd.

ํ•œ๊ตญ๋ฐ”์ด์˜ค๋ž˜๋“œ(์ฃผ)

Complete regulatory portfolio for Biorad Korea Co., Ltd. in South Korea's medical device market. This company has 431 medical devices registered with South Korea MFDS, with registrations dating from Oct 10, 2000 to Dec 16, 2022.

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
431 Devices
Company Overview
Total Devices
431
Address
์„œ์šธํŠน๋ณ„์‹œ ๊ฐ•๋‚จ๊ตฌ ์—ญ์‚ผ๋กœ 114 ,10์ธต(์—ญ์‚ผ๋™,ํ˜„์ฃฝ๋นŒ๋”ฉ)
Registration Timeline
Earliest Approval
Oct 10, 2000
Latest Approval
Dec 16, 2022
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Device Class Distribution
Breakdown of 431 devices by regulatory classification
Unknown
203
47.1% of total
Class II
99
23.0% of total
Class I
83
19.3% of total
Class III
31
7.2% of total
Class IV
15
3.5% of total
Registered Devices (10 most recent shown)
Click on any device for detailed registration information
Device NameClassLicense NumberApproval DateDetail
Blood Transfusion Medical General-purpose Quality Control Substance
์ˆ˜ํ˜ˆ์˜ํ•™๋ฒ”์šฉ์ •๋„๊ด€๋ฆฌ๋ฌผ์งˆ
Class III
In vitro water 22-288
Dec 16, 2022
ABOยท Blood type immunoassay reagent other than RhD
ABOยทRhD์ด์™ธ์˜ํ˜ˆ์•กํ˜•๋ฉด์—ญ๊ฒ€์‚ฌ์‹œ์•ฝ
Class III
In vitro water 22-262
Nov 24, 2022
HIVยท HBVยท HCVยท HTLV Diagnostic Immunoassay Reagent
HIVยทHBVยทHCVยทHTLV์ง„๋‹จ๋ฉด์—ญ๊ฒ€์‚ฌ์‹œ์•ฝ
Class IV
In vitro water 22-242
Nov 08, 2022
Real-time gene amplification device
์‹ค์‹œ๊ฐ„์œ ์ „์ž์ฆํญ์žฅ์น˜
Unknown
In vitro water22-4509
Oct 31, 2022
Tumor-related genetic testing reagents
์ข…์–‘๊ด€๋ จ์œ ์ „์ž๊ฒ€์‚ฌ์‹œ์•ฝ
Class III
In vitro water 21-258
Nov 01, 2021
Clinical Examination Universal Quality Control Substance I.
์ž„์ƒ๊ฒ€์‚ฌ๋ฒ”์šฉ์ •๋„๊ด€๋ฆฌ๋ฌผ์งˆโ… 
Class I
In Vitro Reception No. 20-982
Apr 21, 2020
Clinical Examination Universal Quality Control Substance I.
์ž„์ƒ๊ฒ€์‚ฌ๋ฒ”์šฉ์ •๋„๊ด€๋ฆฌ๋ฌผ์งˆโ… 
Unknown
In Vitro Reception No. 19-2409
Sep 25, 2019
Clinical Examination Universal Quality Control Substance I.
์ž„์ƒ๊ฒ€์‚ฌ๋ฒ”์šฉ์ •๋„๊ด€๋ฆฌ๋ฌผ์งˆโ… 
Unknown
In Vitro Reception No. 19-2420
Sep 25, 2019
Clinical Examination Universal Quality Control Substance I.
์ž„์ƒ๊ฒ€์‚ฌ๋ฒ”์šฉ์ •๋„๊ด€๋ฆฌ๋ฌผ์งˆโ… 
Class I
In Vitro Reception No. 19-2417
Sep 25, 2019
Clinical Examination Universal Quality Control Substance I.
์ž„์ƒ๊ฒ€์‚ฌ๋ฒ”์šฉ์ •๋„๊ด€๋ฆฌ๋ฌผ์งˆโ… 
Unknown
In Vitro Reception No. 19-2404
Sep 25, 2019