Pure Global

Other In Vitro Diagnostics Related Software II.

๊ธฐํƒ€์ฒด์™ธ์ง„๋‹จ๊ด€๋ จ์†Œํ”„ํŠธ์›จ์–ดโ…ก

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 In vitro water23-4092. Approved on Feb 16, 2023. Registered by Roche Diagnostics Korea.

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.

Free Database
Powered by Pure Global AI
MFDS Official Data
Unknown
Basic Information
Item Serial Number
2022003260
License Number
In vitro water23-4092
์ฒด์™ธ์ˆ˜์ธ23-4092ํ˜ธ
Classification Number
P20010.01
Device Class (Risk Classification)
Unknown
Classification Name
Other In Vitro Diagnostics Related Software II.
๊ธฐํƒ€์ฒด์™ธ์ง„๋‹จ๊ด€๋ จ์†Œํ”„ํŠธ์›จ์–ดโ…ก
Official English Name
Other software, classโ…ก, for IVD
Company Information
Entity Name (Company)
Roche Diagnostics Korea
ํ•œ๊ตญ๋กœ์Šˆ์ง„๋‹จ(์ฃผ)
Category
In vitro diagnostic import business
์ฒด์™ธ์ง„๋‹จ์ˆ˜์ž…์—…
Business License Number
์ฒด์™ธ ์ œ 730 ํ˜ธ
Important Dates & Status
Item Approval Date
Feb 16, 2023
Business Permit Date
May 27, 2005
Expiration Period
2023-02-16 ~ 2028-02-15
Model Information
Model Name
uPath enterprise Software
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing