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Roche Diagnostics Korea

ํ•œ๊ตญ๋กœ์Šˆ์ง„๋‹จ(์ฃผ)

Complete regulatory portfolio for Roche Diagnostics Korea in South Korea's medical device market. This company has 1,201 medical devices registered with South Korea MFDS, with registrations dating from Mar 15, 1999 to Sep 25, 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
1,201 Devices
Company Overview
Total Devices
1,201
Address
์„œ์šธํŠน๋ณ„์‹œ ๊ฐ•๋‚จ๊ตฌ ํ…Œํ—ค๋ž€๋กœ108๊ธธ 22 , 4์ธต~8์ธต(๋Œ€์น˜๋™, ์„œ๊ฒฝ๋นŒ๋”ฉ)
Registration Timeline
Earliest Approval
Mar 15, 1999
Latest Approval
Sep 25, 2023
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Device Class Distribution
Breakdown of 1,201 devices by regulatory classification
Unknown
926
77.1% of total
Class III
117
9.7% of total
Class II
74
6.2% of total
Class I
70
5.8% of total
Class IV
14
1.2% of total
Registered Devices (10 most recent shown)
Click on any device for detailed registration information
Device NameClassLicense NumberApproval DateDetail
Cell and Tissue Staining Reagent II
์„ธํฌ๋ฐ์กฐ์ง์—ผ์ƒ‰์‹œ์•ฝII
Unknown
Extracorporeal water seal 23-4770
Sep 25, 2023
Cell and Tissue Staining Reagent II
์„ธํฌ๋ฐ์กฐ์ง์—ผ์ƒ‰์‹œ์•ฝII
Unknown
In Vitro Number 23-4752
Sep 06, 2023
Pathology Tissue Diagnosis Assistant Software II
๋ณ‘๋ฆฌ์กฐ์ง์ง„๋‹จ๋ณด์กฐ์†Œํ”„ํŠธ์›จ์–ดII
Unknown
In Vitro Water No. 23-244
Jun 23, 2023
Genetic testing reagent for high-risk infections
๊ณ ์œ„ํ—˜์„ฑ๊ฐ์—ผ์ฒด์œ ์ „์ž๊ฒ€์‚ฌ์‹œ์•ฝ
Unknown
In Vitro Hydrotherapy No. 23-222
Jun 01, 2023
Blood glucose test strip for clinical examination
์ž„์ƒ๊ฒ€์‚ฌ์šฉํ˜ˆ๋‹น๊ฒ€์‚ฌ์ง€
Unknown
In Vitro Recipient No. 23-4574
May 12, 2023
Pathology Tissue Diagnosis Assistant Software II
๋ณ‘๋ฆฌ์กฐ์ง์ง„๋‹จ๋ณด์กฐ์†Œํ”„ํŠธ์›จ์–ดII
Unknown
In Vitro Water No. 23-197
May 03, 2023
Pathology Tissue Diagnosis Assistant Software II
๋ณ‘๋ฆฌ์กฐ์ง์ง„๋‹จ๋ณด์กฐ์†Œํ”„ํŠธ์›จ์–ดII
Unknown
In Vitro Procedure No. 23-136
Apr 03, 2023
Other In Vitro Diagnostics Related Software II.
๊ธฐํƒ€์ฒด์™ธ์ง„๋‹จ๊ด€๋ จ์†Œํ”„ํŠธ์›จ์–ดโ…ก
Unknown
In vitro water23-4092
Feb 16, 2023
Thyroid function hormone test reagent
๊ฐ‘์ƒ์„ ๊ธฐ๋Šฅํ˜ธ๋ฅด๋ชฌ๊ฒ€์‚ฌ์‹œ์•ฝ
Class II
In vitro 23-4088
Feb 15, 2023
High-risk infection immunoassay reagent
๊ณ ์œ„ํ—˜์„ฑ๊ฐ์—ผ์ฒด๋ฉด์—ญ๊ฒ€์‚ฌ์‹œ์•ฝ
Class III
In vitro water 23-25
Feb 01, 2023