Taiwan FDA registration 14110cb5377b02ba18f716e1606a3df4

"Offretti" Otto scalpel handle (indestructible)

TW: "修弗萊迪" 奧托解剖刀柄(未滅菌)

Taiwan·Risk Class 1·HU-FRIEDY MFG. CO., LLC;; Otto Rüttgers GmbH & Co. KG·Registered Jan 29, 2024 – Jan 29, 2029Active

Registration details

Analysis ID: 14110cb5377b02ba18f716e1606a3df4
Customs Code: DHA09402338303

Company information

Manufacturer: HU-FRIEDY MFG. CO., LLC;; Otto Rüttgers GmbH & Co. KG
Manufacturer Country: United States;;Germany
Authorized Representative: YONG CHIEH ENTERPRISE CO., LTD.

Product details

Intended Use: Limited to the first level identification scope of the "Manual Instruments for General Surgery (I.4800)" of the Measures for the Classification and Grading Management of Medical Equipment.
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4800 Hand Instruments for General Surgery
Import Information: QMS/QSD;; 委託製造;; 輸入

Dates and status

Registration Date: Jan 29, 2024
Expiry Date: Jan 29, 2029

About this record

Access comprehensive regulatory information for "Offretti" Otto scalpel handle (indestructible) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 14110cb5377b02ba18f716e1606a3df4 and manufactured by HU-FRIEDY MFG. CO., LLC;; Otto Rüttgers GmbH & Co. KG. The authorized representative in Taiwan is YONG CHIEH ENTERPRISE CO., LTD..

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