Taiwan FDA registration 9e63962125a7eb1f629c0deb040ee31b

"Arkolai" blood collection pen (unsterilized)

TW: “愛科來”採血筆(未滅菌)

Taiwan·Risk Class 1·Arkray Factory Inc., Head office factory·Registered Mar 18, 2010 – Mar 18, 2025Expired

Registration details

Analysis ID: 9e63962125a7eb1f629c0deb040ee31b
Customs Code: DHA04400862508

Company information

Manufacturer: Arkray Factory Inc., Head office factory
Manufacturer Country: Japan
Authorized Representative: SYNGEN BIOTECH 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: import

Dates and status

Registration Date: Mar 18, 2010
Expiry Date: Mar 18, 2025

About this record

Access comprehensive regulatory information for "Arkolai" blood collection pen (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 9e63962125a7eb1f629c0deb040ee31b and manufactured by Arkray Factory Inc., Head office factory. The authorized representative in Taiwan is SYNGEN BIOTECH CO., LTD..

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