Taiwan FDA registration 4bb48374018e6439bcd2024f98e265f8

"Letuo" Manual Orthopedic Surgical Instruments (Non-sterilized)

TW: "樂拓" 手動式骨科手術器械(未滅菌)

Taiwan·Risk Class 1·Letop Medical Co., Ltd·Registered Nov 11, 2024 – Nov 11, 2029Active

Registration details

Analysis ID: 4bb48374018e6439bcd2024f98e265f8
Customs Code: DHA09600502504

Company information

Manufacturer: Letop Medical Co., Ltd
Manufacturer Country: China
Authorized Representative: A-SPINE Asia Co., Ltd.

Product details

Intended Use: It is limited to the first level of identification scope of manual orthopedic surgical instruments (N.4540) in the management measures for the classification and grading of medical devices.
Product Type (Level 1): N Orthopedics
Product Type (Level 2): N.4540 手動式骨科手術器械
Import Information: Chinese goods;; Input;; QMS/QSD

Dates and status

Registration Date: Nov 11, 2024
Expiry Date: Nov 11, 2029

About this record

Access comprehensive regulatory information for "Letuo" Manual Orthopedic Surgical Instruments (Non-sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 4bb48374018e6439bcd2024f98e265f8 and manufactured by Letop Medical Co., Ltd. The authorized representative in Taiwan is A-SPINE Asia Co., Ltd..

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