Taiwan FDA registration 60bd73fae9239bc95bbe86103239db32

OC-Calibrator 1 kit

TW: "榮研" 免疫法便中血紅素定量分析系統-校正組1

Taiwan·Risk Class 2·MD·EIKEN CHEMICAL CO., LTD. NASU PLANT·Registered Apr 07, 2020 – Apr 07, 2025Expired

Registration details

Analysis ID: 60bd73fae9239bc95bbe86103239db32
License Form: Ministry of Health Medical Device Import No. 033463
Customs Code: DHA05603346300

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 a calibration solution for the determination of heme (Hb) in stool using an immunochemical automated analysis instrument. The matching reagent of the product is "Eiken" OC-AUTO 3.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A1150 calibrate
Import Information: Imported from abroad

Dates and status

Registration Date: Apr 07, 2020
Expiry Date: Apr 07, 2025

About this record

Access comprehensive regulatory information for OC-Calibrator 1 kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 60bd73fae9239bc95bbe86103239db32 and manufactured by EIKEN CHEMICAL CO., LTD. NASU PLANT. The authorized representative in Taiwan is HUI SHENG INTERNATIONAL CORP..

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