South Korea MFDS registration In Vitro Recipient No. 23-4574
Blood glucose test strip for clinical examination
KO: 임상검사용혈당검사지
South Korea·Unknown·Roche Diagnostics Korea·Approved May 12, 2023Basic information
- Item Serial Number
- 2023002827
- License Number
- In Vitro Recipient No. 23-4574
- Classification Number
- J13010.01
- Device Class (Risk Classification)
- Unknown
- Classification Name
- Blood glucose test strip for clinical examination
- Official English Name
- Clinical IVD strip for glucose strip
체외수인23-4574호
임상검사용혈당검사지
Company information
- Category
- In vitro diagnostic import business
- Business License Number
- 체외 제 730 호
체외진단수입업
Important dates & status
- Item Approval Date
- May 12, 2023
- Business Permit Date
- May 27, 2005
- Expiration Period
- 2023-05-12 ~ 2028-05-11
Model information
- Model Name
- cobas GLU test strips
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 Recipient No. 23-4574. Approved on May 12, 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 DatabasePowered by Pure Global AIMFDS Official DataUnknown