Taiwan FDA registration 8d36e562b93d8e6b39f8f1b4ad615a9b

"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·Hitachi, Ltd. Healthcare Tokyo Works·Registered Oct 01, 2021 – Oct 31, 2025Expired
Registration details
Analysis ID
8d36e562b93d8e6b39f8f1b4ad615a9b
Customs Code
DHA08402000400
Company information
Manufacturer Country
Japan
Authorized Representative
HUI SHENG INTERNATIONAL CORP.
Product details
Intended Use
Limited to the classification and grading management of medical devices, the first level identification range of immunoturbimetric meter (C.4540).
Product Type (Level 1)
C Immunology and microbiology
Product Type (Level 2)
C.4540 Immunoturbidimeter
Import Information
輸入;; 委託製造;; QMS/QSD
Dates and status
Registration Date
Oct 01, 2021
Expiry Date
Oct 31, 2025
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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 8d36e562b93d8e6b39f8f1b4ad615a9b and manufactured by 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 EIKEN CHEMICAL CO., LTD.;; HITACHI HEALTHCARE MANUFACTURING, LTD. ANALYTICAL SYSTEMS KASHIWA FACTORY, 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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