Taiwan FDA registration ad3de95609e4c2fcc6c0e934f33029f2

"Elekoda" medical linear accelerator

TW: “醫科達”醫用直線加速器

Taiwan·Risk Class 2·Elekta Beijing Medical Systems Co.,Ltd.·Registered Jul 20, 2020 – Jul 20, 2025Expired

Registration details

Analysis ID: ad3de95609e4c2fcc6c0e934f33029f2
Customs Code: DHAS9200114101

Company information

Manufacturer: Elekta Beijing Medical Systems Co.,Ltd.
Manufacturer Country: China
Authorized Representative: CHIU HO MEDICAL SYSTEM CO., LTD.

Product details

Intended Use: For details, it is Chinese approved copy of the imitation order
Product Type (Level 1): P Radiology Science
Product Type (Level 2): P.5050 Medical Charged Particle Radiotherapy System
Import Information: 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". Chinese goods;; 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: Jul 20, 2020
Expiry Date: Jul 20, 2025

About this record

Access comprehensive regulatory information for "Elekoda" medical 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 ad3de95609e4c2fcc6c0e934f33029f2 and manufactured by Elekta Beijing Medical Systems Co.,Ltd.. The authorized representative in Taiwan is CHIU HO MEDICAL SYSTEM CO., LTD..

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