Taiwan FDA registration c3c1dbd55054daeecfb0477b41b7e5be
Bardi Iron Creatine Kinase MB Isoenzyme Test-Quality Fluid
TW: 巴迪鐵克肌酸激酶 MB 同功酶檢驗試劑-品管液
Taiwan·Risk Class 2·Boditech Med Inc.·Registered Dec 03, 2024 – Dec 03, 2029ActiveRegistration details
- Analysis ID
- c3c1dbd55054daeecfb0477b41b7e5be
- Customs Code
- DHA05603751908
Company information
- Manufacturer
- Boditech Med Inc.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- MEDRICH INSTRUMENT CO., LTD.
Product details
- Intended Use
- This product is used for in vitro diagnostics and is used for quality control of creatine kinase MB isoenzyme test reagent set.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical)
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Dec 03, 2024
- Expiry Date
- Dec 03, 2029
About this record
Access comprehensive regulatory information for Bardi Iron Creatine Kinase MB Isoenzyme Test-Quality Fluid in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c3c1dbd55054daeecfb0477b41b7e5be and manufactured by Boditech Med Inc.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Free DatabasePowered by Pure Global AI89,000+ Devices