Taiwan FDA registration 40253d93e2a7cee53a441e8ff128f79b

"Omeco" dental orthodontic equipment and accessories (not indepleted)

TW: "奧美科" 牙科矯正裝置及其附件(未滅菌)

Taiwan·Risk Class 1·ORMCO Corporation;; ACME Monaco Corporation·Registered Aug 30, 2024 – Aug 30, 2029Active

Registration details

Analysis ID: 40253d93e2a7cee53a441e8ff128f79b
Customs Code: DHA09402358808

Company information

Manufacturer: ORMCO Corporation;; ACME Monaco Corporation
Manufacturer Country: United States
Authorized Representative: NOBEL BIOCARE TAIWAN CO., LTD.

Product details

Intended Use: It is limited to the scope of the first level of identification of dental orthodontic devices and their accessories (F.5410) in the classification and grading management measures for medical devices.
Product Type (Level 1): F Dentistry
Product Type (Level 2): F.5410 Dental orthodox equipment and accessories thereof
Import Information: QMS/QSD;; 委託製造;; 輸入

Dates and status

Registration Date: Aug 30, 2024
Expiry Date: Aug 30, 2029

About this record

Access comprehensive regulatory information for "Omeco" dental orthodontic equipment and accessories (not indepleted) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 40253d93e2a7cee53a441e8ff128f79b and manufactured by ORMCO Corporation;; ACME Monaco Corporation. The authorized representative in Taiwan is NOBEL BIOCARE TAIWAN CO., LTD..

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