Taiwan FDA registration 8a659dde7598445bb4f243ca98831f38

"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 HEALTHCARE MANUFACTURING, LTD. ANALYTICAL SYSTEMS KASHIWA FACTORY·Registered Jan 09, 2019 – Jan 08, 2024Cancelled
Registration details
Analysis ID
8a659dde7598445bb4f243ca98831f38
Customs Code
DHA09402000406
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
QMS/QSD;; 委託製造;; 輸入
Dates and status
Registration Date
Jan 09, 2019
Expiry Date
Jan 08, 2024
Cancellation Date
Sep 30, 2021
Cancellation information
Status
Logged out
Reason
轉為登錄字號
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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 8a659dde7598445bb4f243ca98831f38 and manufactured by EIKEN CHEMICAL CO., LTD.;; HITACHI HEALTHCARE MANUFACTURING, LTD. ANALYTICAL SYSTEMS KASHIWA FACTORY. 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, Ltd. Healthcare Tokyo Works, 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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