South Korea MFDS registration In Vitro Reception No. 22-318
Automatic medical separation method clinical chemistry analysis device
KO: 의료용분리방식임상화학자동분석장치
Basic information
- Item Serial Number
- 2022000971
- License Number
- In Vitro Reception No. 22-318
- Classification Number
- J01020.01(1)
- Device Class (Risk Classification)
- Class I
- Classification Name
- Automatic medical separation method clinical chemistry analysis device
- Official English Name
- Clinical chemistry automated analyser
체외수신22-318호
의료용분리방식임상화학자동분석장치
Company information
- Entity Address
- 서울특별시 서초구 남부순환로 2477 9층 일부(서초동)
- Manufacturer
- JEOL Ltd.
- Category
- Import business
- Business License Number
- 체외 제 3842 호
수입업
Important dates & status
- Item Approval Date
- Feb 24, 2022
- Business Permit Date
- May 19, 2016
- Expiration Period
- 2022-02-24 ~ 2027-02-23
- For Export
- 아니오
Model information
- Model Name
- JCA-BM8060
About this record
This Class I medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number In Vitro Reception No. 22-318. Approved on Feb 24, 2022. Registered by JW Bioscience Co., Ltd..
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