Taiwan FDA registration 8b2016c7b33958e5ba2ac12d401e1e28

"AMI" Gynecologic general manual instrument (Non-sterile)

TW: "艾恩斯" 婦科用一般手動器械 (未滅菌)

Taiwan·Risk Class 1·MD·AMI INC.·Registered Feb 19, 2020 – Feb 19, 2025Expired

Registration details

Analysis ID: 8b2016c7b33958e5ba2ac12d401e1e28
License Form: Ministry of Health Medical Device Import No. 021293
Customs Code: DHA09402129305

Company information

Manufacturer: AMI INC.
Manufacturer Country: Korea, Republic of
Authorized Representative: SERVICETECH INTERNATIONAL INC.

Product details

Intended Use: Limited to the first level identification scope of the Measures for the Administration of Medical Devices "General Manual Instruments for Obstetrics and Gynecology (L.4520)".
Product Type (Level 1): l Devices for obstetrics and gynecology
Product Type (Level 2): L4520 General manual instruments for obstetrics and gynecology
Import Information: Imported from abroad

Dates and status

Registration Date: Feb 19, 2020
Expiry Date: Feb 19, 2025

About this record

Access comprehensive regulatory information for "AMI" Gynecologic general manual instrument (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 8b2016c7b33958e5ba2ac12d401e1e28 and manufactured by AMI INC.. The authorized representative in Taiwan is SERVICETECH INTERNATIONAL INC..

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