Taiwan FDA registration 638f5fae57507ea32ffe8e9cb5209e4e

"Elekoda" digital linear accelerator

TW: “醫科達”數位式直線加速器

Taiwan·Risk Class 2·Elekta Solutions AB;; Elekta Limited·Registered Mar 04, 2023 – Mar 04, 2028Active

Registration details

Analysis ID: 638f5fae57507ea32ffe8e9cb5209e4e
Customs Code: DHAS5603632307

Company information

Manufacturer: Elekta Solutions AB;; Elekta Limited
Manufacturer Country: United Kingdom;;Sweden
Authorized Representative: CHIU HO MEDICAL SYSTEM CO., LTD.

Product details

Intended Use: Details are as detailed as approved Chinese instructions
Product Type (Level 1): P Radiology Science
Product Type (Level 2): P.5050 Medical Charged Particle Radiotherapy System
Import Information: 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

Registration Date: Mar 04, 2023
Expiry Date: Mar 04, 2028

About this record

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..

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