Taiwan FDA registration adfa1142b5b4952e881a40117a535e49

"Bioretec" Orthopedic manual surgical instrument (Non-Sterile)

TW: "百優" 手動式骨科手術器械 (未滅菌)

Taiwan·Risk Class 1·MD·Bioretec Ltd.·Registered Nov 23, 2018 – Nov 23, 2023Expired

Registration details

Analysis ID: adfa1142b5b4952e881a40117a535e49
License Form: Ministry of Health Medical Device Import No. 019842
Customs Code: DHA09401984207

Company information

Manufacturer: Bioretec Ltd.
Manufacturer Country: Finland
Authorized Representative: SINCERE BIOTECH 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

Dates and status

Registration Date: Nov 23, 2018
Expiry Date: Nov 23, 2023

About this record

Access comprehensive regulatory information for "Bioretec" Orthopedic manual surgical instrument (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 adfa1142b5b4952e881a40117a535e49 and manufactured by Bioretec Ltd.. The authorized representative in Taiwan is SINCERE BIOTECH CO., LTD..

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