Taiwan FDA registration 579b2a3d61cbd8c0a2889a7ecce9dfff

"Hitachi" diagnostic X-ray tube sleeve (unsterilized)

TW: "日立" 診斷用X光球管套組(未滅菌)
Taiwan flagTaiwan·Risk Class 1·HITACHI HEALTHCARE MANUFACTURING, LTD. MOBARA BRANCH FACTORY·Registered Sep 09, 2016 – Sep 09, 2026Active
Registration details
Analysis ID
579b2a3d61cbd8c0a2889a7ecce9dfff
Customs Code
DHAS9401698203
Company information
Manufacturer Country
Japan
Authorized Representative
PROMED INSTRUMENT CO., LTD.
Product details
Intended Use
Limited to the first level identification range of the "X-ray tube sleeve assembly for diagnosis (P.1760)" of the Measures for the Classification and Grading Management of Medical Equipment.
Product Type (Level 1)
P Radiology Science
Product Type (Level 2)
P.1760 診斷用X光球管套組件
Import Information
Input;; Consent letter must be attached to the import (consent from the Atomic Energy Commission must be obtained for each import)
Dates and status
Registration Date
Sep 09, 2016
Expiry Date
Sep 09, 2026
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About this record

Access comprehensive regulatory information for "Hitachi" diagnostic X-ray tube sleeve (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 579b2a3d61cbd8c0a2889a7ecce9dfff and manufactured by HITACHI HEALTHCARE MANUFACTURING, LTD. MOBARA BRANCH FACTORY. The authorized representative in Taiwan is PROMED INSTRUMENT CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including HITACHI MEDICAL CORPORATION, MEDICAL SYSTEM OPERATIONS GROUP, KASHIWA, and 1 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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