South Korea MFDS registration In vitro water22-4509

Real-time gene amplification device

KO: 실시간유전자증폭장치
South Korea flagSouth Korea·Unknown·Biorad Korea Co., Ltd.·Approved Oct 31, 2022
Basic information
Item Serial Number
2022005533
License Number
In vitro water22-4509
체외수인22-4509호
Classification Number
N01030.01
Device Class (Risk Classification)
Unknown
Classification Name
Real-time gene amplification device
실시간유전자증폭장치
Official English Name
Real-time gene amplificator, nucleic acid
Company information
Entity Name (Company)
Biorad Korea Co., Ltd.
한국바이오래드(주)
Category
In vitro diagnostic import business
체외진단수입업
Business License Number
체외 제 719 호
Important dates & status
Item Approval Date
Oct 31, 2022
Business Permit Date
May 26, 2005
Expiration Period
2022-10-31 ~ 2027-10-30
Model information
Model Name
CFX Opus 384 Dx Real-Time PCR System
About this record

This Unknown medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number In vitro water22-4509. Approved on Oct 31, 2022. Registered by Biorad 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.

Free DatabasePowered by Pure Global AIMFDS Official DataUnknown