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)
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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