Taiwan FDA registration 8207a098b31e15aabd5ef2a801a9256a

"PENTAX MEDICAL" Medical image storage device (Non-Sterile)

TW: "賓得醫療" 醫學影像儲存裝置 (未滅菌)

Taiwan·Risk Class 1·MD·PENTAX OF AMERICA, INC.·Registered Mar 02, 2017 – Mar 02, 2027Active

Registration details

Analysis ID: 8207a098b31e15aabd5ef2a801a9256a
License Form: Ministry of Health Medical Device Import No. 017549
Customs Code: DHA09401754902

Company information

Manufacturer: PENTAX OF AMERICA, INC.
Manufacturer Country: United States
Authorized Representative: PENTAX MEDICAL SINGAPORE PTE. LTD. TAIWAN BRANCH(SINGAPORE)

Product details

Intended Use: Limited to the first-level recognition scope of the Measures for the Administration of Medical Devices "Medical Image Storage Devices (P.2010)".
Product Type (Level 1): P Devices for radiology
Product Type (Level 2): P2010 Medical Image Storage Device
Import Information: Imported from abroad

Dates and status

Registration Date: Mar 02, 2017
Expiry Date: Mar 02, 2027

About this record

Access comprehensive regulatory information for "PENTAX MEDICAL" Medical image storage device (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 8207a098b31e15aabd5ef2a801a9256a and manufactured by PENTAX OF AMERICA, INC.. The authorized representative in Taiwan is PENTAX MEDICAL SINGAPORE PTE. LTD. TAIWAN BRANCH(SINGAPORE).

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