Taiwan FDA registration 5c08699df4d6e51eec3184d154c4dafb

"Intergola" General Surgical Hand Device (Indepleted Bacteria)

TW: "英特戈拉" 一般手術用手動式器械(未滅菌)

Taiwan·Risk Class 1·Integra LifeSciences Production Corporation;; HEBUmedical GmbH·Registered Feb 19, 2024 – Feb 19, 2029Active

Registration details

Analysis ID: 5c08699df4d6e51eec3184d154c4dafb
Customs Code: DHA09402339701

Company information

Manufacturer: Integra LifeSciences Production Corporation;; HEBUmedical GmbH
Manufacturer Country: United States;;Germany
Authorized Representative: ASIA-COL INTERNATIONAL 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: 委託製造;; QMS/QSD;; 輸入

Dates and status

Registration Date: Feb 19, 2024
Expiry Date: Feb 19, 2029

About this record

Access comprehensive regulatory information for "Intergola" General Surgical Hand Device (Indepleted Bacteria) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 5c08699df4d6e51eec3184d154c4dafb and manufactured by Integra LifeSciences Production Corporation;; HEBUmedical GmbH. The authorized representative in Taiwan is ASIA-COL INTERNATIONAL CO., 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.