Taiwan FDA registration c537b7b670ea71dbd65431e4c46edbde
“EIKEN” OC-AUTO 3 Liquid Control LV1, LV2, LV3
TW: “榮研”便中血紅素液態品管液 濃度1,2,3
Taiwan·Risk Class 2·MD·EIKEN CHEMICAL CO., LTD NASU PLANT·Registered Mar 12, 2018 – Mar 12, 2028ActiveRegistration details
- Analysis ID
- c537b7b670ea71dbd65431e4c46edbde
- License Form
- Ministry of Health Medical Device Import No. 030521
- Customs Code
- DHA05603052102
Company information
- Manufacturer
- EIKEN CHEMICAL CO., LTD NASU PLANT
- Manufacturer Country
- Japan
- Authorized Representative
- HUI SHENG INTERNATIONAL CORP.
Product details
- Intended Use
- This product is used as an internal quality control in the quantitative immunoassay system for heme in feces using "Rongyan".
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B6550 Occult blood test
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Mar 12, 2018
- Expiry Date
- Mar 12, 2028
About this record
Access comprehensive regulatory information for “EIKEN” OC-AUTO 3 Liquid Control LV1, LV2, LV3 in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c537b7b670ea71dbd65431e4c46edbde and manufactured by EIKEN CHEMICAL CO., LTD NASU PLANT. The authorized representative in Taiwan is HUI SHENG INTERNATIONAL CORP..
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