Taiwan FDA registration 6afe1d1433486450d3ae86935bd8e480

"Rongyan" Immunoassay Heme Automatic Analyzer (Unsterilized)

TW: "榮研" 免疫法便中血紅素自動分析儀 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·EIKEN CHEMICAL CO., LTD.;; Hitachi, Ltd. Healthcare Tokyo Works·Registered Sep 11, 2015 – Sep 11, 2020Cancelled
Registration details
Analysis ID
6afe1d1433486450d3ae86935bd8e480
Customs Code
DHA09401566007
Company information
Manufacturer Country
Japan
Authorized Representative
HUI SHENG INTERNATIONAL CORP.
Product details
Intended Use
Limited to the first level identification range of the Measures for the Administration of Medical Devices "Immunoturbimetric Meter (C.4540)".
Product Type (Level 1)
C Immunology and microbiology
Product Type (Level 2)
C.4540 Immunoturbidimeter
Import Information
委託製造;; QMS/QSD;; 輸入
Dates and status
Registration Date
Sep 11, 2015
Expiry Date
Sep 11, 2020
Cancellation Date
Jul 15, 2022
Cancellation information
Status
Logged out
Reason
未展延而逾期者
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About this record

Access comprehensive regulatory information for "Rongyan" Immunoassay Heme Automatic Analyzer (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 6afe1d1433486450d3ae86935bd8e480 and manufactured by EIKEN CHEMICAL CO., LTD.;; Hitachi, Ltd. Healthcare Tokyo Works. The authorized representative in Taiwan is HUI SHENG INTERNATIONAL CORP..

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Hitachi, Ltd. Healthcare Tokyo Works, EIKEN CHEMICAL CO., LTD.;; HITACHI HEALTHCARE MANUFACTURING, LTD. ANALYTICAL SYSTEMS KASHIWA FACTORY, and 2 recent registrations in the same category. 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.

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