Taiwan FDA registration 178fbe7af7d4757de914cc23bd76e12f

"Aynder" Diagnostic X-ray Tube Sleeve Assembly (Non-Sterile)

TW: "愛恩德" 診斷用X光球管套組件(未滅菌)

Taiwan·Risk Class 1·I.M.D. Generators S.r.l.·Registered Jan 31, 2024 – Jan 31, 2029Active

Registration details

Analysis ID: 178fbe7af7d4757de914cc23bd76e12f
Customs Code: DHAS9402338502

Company information

Manufacturer: I.M.D. Generators S.r.l.
Manufacturer Country: Italy
Authorized Representative: PIEZOMED INTERNATIONAL INC.

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: QMS/QSD;; 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: Jan 31, 2024
Expiry Date: Jan 31, 2029

About this record

Access comprehensive regulatory information for "Aynder" Diagnostic X-ray Tube Sleeve Assembly (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 178fbe7af7d4757de914cc23bd76e12f and manufactured by I.M.D. Generators S.r.l.. The authorized representative in Taiwan is PIEZOMED INTERNATIONAL INC..

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