Taiwan FDA registration b9f602a931d707a13b50600712e6c93f

Ozaki type Avigno heart valve complement sizer (sterilized)

TW: 尾崎式愛維尼奧心臟瓣膜彌補物尺寸器(滅菌)

Taiwan·Risk Class 1·Hantel Technologies, Inc.;; Japanese Organization for Medical Device Development Inc.·Registered Nov 08, 2019 – Nov 08, 2024Expired

Registration details

Analysis ID: b9f602a931d707a13b50600712e6c93f
Customs Code: DHA09402101401

Company information

Manufacturer: Hantel Technologies, Inc.;; Japanese Organization for Medical Device Development Inc.
Manufacturer Country: United States;;Japan
Authorized Representative: HEALTH RIVER INC.

Product details

Intended Use: It is limited to the first level of identification scope of the Dimension Device (E.3945) of the Classification and Grading Management Measures for Medical Devices.
Product Type (Level 1): E Cardiovascular Medicine Science
Product Type (Level 2): E.3945 Dimensioning apparatus for heart valves
Import Information: 委託製造;; 輸入;; QMS/QSD

Dates and status

Registration Date: Nov 08, 2019
Expiry Date: Nov 08, 2024

About this record

Access comprehensive regulatory information for Ozaki type Avigno heart valve complement sizer (sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b9f602a931d707a13b50600712e6c93f and manufactured by Hantel Technologies, Inc.;; Japanese Organization for Medical Device Development Inc.. The authorized representative in Taiwan is HEALTH RIVER INC..

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