Taiwan FDA registration 0adef1608f74ca6ce316d88fbaa7d6c0

"Hetjia" nitrile gloves for patient examination (unsterilized) (powder-free)

TW: "賀特佳" 病患檢查用丁腈手套(未滅菌)(無粉)

Taiwan·Risk Class 1·HARTALEGA NGC SDN. BHD.·Registered Nov 02, 2022 – Nov 02, 2027Active

Registration details

Analysis ID: 0adef1608f74ca6ce316d88fbaa7d6c0
Customs Code: DHA09402294106

Company information

Manufacturer: HARTALEGA NGC SDN. BHD.
Manufacturer Country: Malaysia
Authorized Representative: Tronmed CO., LTD.

Product details

Intended Use: Limited to the first level of identification scope of the Measures for the Classification and Grading of Medical Equipment "Gloves for Patient Examination (J.6250)".
Product Type (Level 1): J General hospital and personal use equipment
Product Type (Level 2): J.6250 病患檢查用手套
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Nov 02, 2022
Expiry Date: Nov 02, 2027

About this record

Access comprehensive regulatory information for "Hetjia" nitrile gloves for patient examination (unsterilized) (powder-free) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 0adef1608f74ca6ce316d88fbaa7d6c0 and manufactured by HARTALEGA NGC SDN. BHD.. The authorized representative in Taiwan is Tronmed CO., LTD..

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