Taiwan FDA registration 8dc38e91ba03bc5a94940dd8e23f08fe

"Horojet" Ekviva breast tissue atherectomy probe

TW: “豪洛捷”艾克維瓦乳房組織旋切探針

Taiwan·Risk Class 2·HOLOGIC, INC.;; Hologic Surgical Products Costa Rica, S.R.L.·Registered Sep 26, 2023 – Sep 26, 2028Active

Registration details

Analysis ID: 8dc38e91ba03bc5a94940dd8e23f08fe
Customs Code: DHA05603674601

Company information

Manufacturer: HOLOGIC, INC.;; Hologic Surgical Products Costa Rica, S.R.L.
Manufacturer Country: Costa Rica;;United States
Authorized Representative: QUALTECH CONSULTING CORPORATION

Product details

Intended Use: Details are as detailed as approved Chinese instructions
Product Type (Level 1): H Gastroenterology and urology
Product Type (Level 2): H.1075 腸胃科-泌尿科生檢器械
Import Information: import

Dates and status

Registration Date: Sep 26, 2023
Expiry Date: Sep 26, 2028

About this record

Access comprehensive regulatory information for "Horojet" Ekviva breast tissue atherectomy probe in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8dc38e91ba03bc5a94940dd8e23f08fe and manufactured by HOLOGIC, INC.;; Hologic Surgical Products Costa Rica, S.R.L.. The authorized representative in Taiwan is QUALTECH CONSULTING CORPORATION.

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