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"Elekoda" digital linear accelerator - Taiwan Registration 638f5fae57507ea32ffe8e9cb5209e4e

Access comprehensive regulatory information for "Elekoda" digital linear accelerator in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 638f5fae57507ea32ffe8e9cb5209e4e and manufactured by Elekta Solutions AB;; Elekta Limited. The authorized representative in Taiwan is CHIU HO MEDICAL SYSTEM CO., LTD..

This page provides complete technical specifications, regulatory compliance details. 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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638f5fae57507ea32ffe8e9cb5209e4e
Registration Details
Taiwan FDA Registration: 638f5fae57507ea32ffe8e9cb5209e4e
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Device Details

"Elekoda" digital linear accelerator
TW: โ€œ้†ซ็ง‘้”โ€ๆ•ธไฝๅผ็›ด็ทšๅŠ ้€Ÿๅ™จ
Risk Class 2

Registration Details

638f5fae57507ea32ffe8e9cb5209e4e

DHAS5603632307

Company Information

United Kingdom;;Sweden

Product Details

Details are as detailed as approved Chinese instructions

P Radiology Science

P.5050 Medical Charged Particle Radiotherapy System

Input;; The use of this device shall comply with the provisions of the "Administrative Measures for the Implementation or Use of Medical Devices for Specific Medical Technology Inspection and Testing". Consent letter must be attached to the import (consent from the Atomic Energy Commission must be obtained for each import)

Dates and Status

Mar 04, 2023

Mar 04, 2028