Taiwan FDA registration 028a1470b7628219a7e7d16a7d9a675b

"Autome" Cobika Manual Instruments for Surgery (Sterilization)

TW: “歐特美”可比卡手術用手動式器械 (滅菌)

Taiwan·Risk Class 1·OSTEOMED·Registered Sep 09, 2010 – Sep 09, 2025Expired

Registration details

Analysis ID: 028a1470b7628219a7e7d16a7d9a675b
Customs Code: DHA04400917508

Company information

Manufacturer: OSTEOMED
Manufacturer Country: United States
Authorized Representative: ALSTRONG SCIENTIFIC INTERNATIONAL 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: Input;; QMS/QSD

Dates and status

Registration Date: Sep 09, 2010
Expiry Date: Sep 09, 2025

About this record

Access comprehensive regulatory information for "Autome" Cobika Manual Instruments for Surgery (Sterilization) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 028a1470b7628219a7e7d16a7d9a675b and manufactured by OSTEOMED. The authorized representative in Taiwan is ALSTRONG SCIENTIFIC INTERNATIONAL LTD..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.