Taiwan FDA registration b0ed6fc4e974281f14699edc9c98d40c

"Singular" positron/computed tomography system

TW: "奇異"正子/電腦斷層掃描系統
Taiwan flagTaiwan·Risk Class 2·GE MEDICAL SYSTEMS·Registered Aug 07, 2006 – Aug 07, 2026Active
Registration details
Analysis ID
b0ed6fc4e974281f14699edc9c98d40c
Customs Code
DHAS0601697302
Company information
Manufacturer
GE MEDICAL SYSTEMS
Manufacturer Country
United States
Authorized Representative
GE MEDICAL SYSTEMS TAIWAN, LTD.
Product details
Intended Use
This device combines CT and PET functions to capture the image data of the two in one examination step and provide the spatial relationship between the two.
Product Type (Level 1)
P Radiology Science
Product Type (Level 2)
P.1200 Radiology CT system
Import Information
Consent must be attached to the import (with the consent of the Atomic Energy Commission must be obtained for each import); Input;; A consent form is required for each entry (a consent letter from the approved hospital clinic of the Department is required for each entry)
Dates and status
Registration Date
Aug 07, 2006
Expiry Date
Aug 07, 2026
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About this record

Access comprehensive regulatory information for "Singular" positron/computed tomography system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b0ed6fc4e974281f14699edc9c98d40c and manufactured by GE MEDICAL SYSTEMS. The authorized representative in Taiwan is GE MEDICAL SYSTEMS TAIWAN, LTD..

This page provides complete technical specifications, regulatory compliance details, 3 companies making similar products including GE MEDICAL SYSTEMS, GE MEDICAL SYSTEMS, LLC, and 5 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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