Taiwan FDA registration 58a9686a04d3944ba7d7e474b8cfcfee

"Megaspine" spinal process instruments (Non-Sterile)

TW: "兆峰"脊柱脊突間手術器械(未滅菌)

Taiwan·Risk Class 1·MD·Beijing Fule Science and Technology Development Co., Ltd.·Registered Jan 28, 2021 – Jan 28, 2026Expired

Registration details

Analysis ID: 58a9686a04d3944ba7d7e474b8cfcfee
License Form: Ministry of Health Medical Device Land Transport No. 004428
Customs Code: DHA09600442808

Company information

Manufacturer: Beijing Fule Science and Technology Development Co., Ltd.
Manufacturer Country: China
Authorized Representative: MEGASPINE MEDICAL CO., LTD.

Product details

Intended Use: Limited to the first level identification range of manual orthopedic surgical instruments (N.4540) of the Measures for the Administration of Medical Equipment.
Product Type (Level 1): N Orthopedic devices
Product Type (Level 2): N4540 Manual osteologic surgery instrument
Import Information: Imported from abroad; Made in China

Dates and status

Registration Date: Jan 28, 2021
Expiry Date: Jan 28, 2026

About this record

Access comprehensive regulatory information for "Megaspine" spinal process instruments (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 58a9686a04d3944ba7d7e474b8cfcfee and manufactured by Beijing Fule Science and Technology Development Co., Ltd.. The authorized representative in Taiwan is MEGASPINE MEDICAL CO., LTD..

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