Pure Global

Hemocytosis reagent

ํ˜ˆ๊ตฌ์—ผ์ƒ‰์‹œ์•ฝ

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 Reception No. 23-1343. Approved on May 26, 2023. Registered by Shinyang Chemical 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.

Free Database
Powered by Pure Global AI
MFDS Official Data
Unknown
Basic Information
Item Serial Number
2023003127
License Number
In Vitro Reception No. 23-1343
์ฒด์™ธ์ˆ˜์‹ 23-1343ํ˜ธ
Classification Number
J09010.01
Device Class (Risk Classification)
Unknown
Classification Name
Hemocytosis reagent
ํ˜ˆ๊ตฌ์—ผ์ƒ‰์‹œ์•ฝ
Official English Name
IVD reagents for hematological stains
Company Information
Entity Name (Company)
Shinyang Chemical Co., Ltd.
์‹ ์–‘ํ™”ํ•™์•ฝํ’ˆ(์ฃผ)
Category
In vitro diagnostic import business
์ฒด์™ธ์ง„๋‹จ์ˆ˜์ž…์—…
Business License Number
์ฒด์™ธ ์ œ 415 ํ˜ธ
Important Dates & Status
Item Approval Date
May 26, 2023
Business Permit Date
Apr 12, 2005
Expiration Period
2023-05-26 ~ 2028-05-25
Model Information
Model Name
Procedure No. R4132-120ML
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing