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Drug susceptibility and resistance microorganism test reagent

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This Unknown medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / ์‹ํ’ˆ์˜์•ฝํ’ˆ์•ˆ์ „์ฒ˜) under license number Extracorporeal water seal 23-4872. Approved on Nov 21, 2023. Registered by Biomeriu Korea Co., Ltd..

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 devices in South Korea.

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MFDS Official Data
Unknown
Basic Information
Item Serial Number
2023006573
License Number
Extracorporeal water seal 23-4872
์ฒด์™ธ์ˆ˜์ธ23-4872ํ˜ธ
Classification Number
M02020.01
Device Class (Risk Classification)
Unknown
Classification Name
Drug susceptibility and resistance microorganism test reagent
์•ฝ์ œ๊ฐ์ˆ˜์„ฑ๋ฐ๋‚ด์„ฑ๋ฏธ์ƒ๋ฌผ๊ฒ€์‚ฌ์‹œ์•ฝ
Official English Name
IVD reagents and media for antibiotic susceptibility
Company Information
Entity Name (Company)
Biomeriu Korea Co., Ltd.
(์ฃผ)๋น„์˜ค๋ฉ”๋ฆฌ์œผ์ฝ”๋ฆฌ์•„
Category
In vitro diagnostic import business
์ฒด์™ธ์ง„๋‹จ์ˆ˜์ž…์—…
Business License Number
์ฒด์™ธ ์ œ 687 ํ˜ธ
Important Dates & Status
Item Approval Date
Nov 21, 2023
Business Permit Date
May 24, 2005
Expiration Period
2023-11-21 ~ 2028-11-20
Model Information
Model Name
ETEST Ceftazidime/Avibactam(CZA) (423802)
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