Taiwan FDA registration b90d2241bef08a097f06f640da0c510b

"Omko" CAD/CAM optical mold taking system (unsterilized)

TW: "歐姆可" CAD/CAM光學取模系統 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·ORMCO CORPORATION·Registered Oct 30, 2015 – Oct 30, 2020Cancelled
Registration details
Analysis ID
b90d2241bef08a097f06f640da0c510b
Customs Code
DHA09401580000
Company information
Manufacturer
ORMCO CORPORATION
Manufacturer Country
United States
Authorized Representative
YONG CHIEH ENTERPRISE CO., LTD.
Product details
Intended Use
Limited to the first level recognition range of CAD/CAM optical mold taking system (F.3661) for the management of medical equipment.
Product Type (Level 1)
F Dentistry
Product Type (Level 2)
F.3661 CAD/CAM光學取模系統
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
Oct 30, 2015
Expiry Date
Oct 30, 2020
Cancellation Date
Jul 15, 2022
Cancellation information
Status
Logged out
Reason
未展延而逾期者
About this record

Access comprehensive regulatory information for "Omko" CAD/CAM optical mold taking system (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b90d2241bef08a097f06f640da0c510b and manufactured by ORMCO CORPORATION. The authorized representative in Taiwan is YONG CHIEH ENTERPRISE CO., LTD..

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