Taiwan FDA registration 8a31c27cca86296036a192788edaad04

"PENTAX MEDICAL" Surgical camera and accessories (Non-Sterile)

TW: "賓得醫療" 外科手術用照相機及其附件 (未滅菌)

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

Registration details

Analysis ID: 8a31c27cca86296036a192788edaad04
License Form: Ministry of Health Medical Device Import No. 017548
Customs Code: DHA09401754800

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 of identification scope of the Measures for the Administration of Medical Devices "Surgical Cameras and Their Accessories (I.4160)".
Product Type (Level 1): I General and plastic surgical devices
Product Type (Level 2): I4160 Surgical Camera and Its Accessories
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" Surgical camera and accessories (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 8a31c27cca86296036a192788edaad04 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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