Taiwan FDA registration 4e444071ca471323aeb4d5cd1da869a1

"SEKISUI" Pureauto S LD-P (non-sterile)

TW: "積水" 普優歐特乳酸脫氫酶P試驗試劑 (未滅菌)

Taiwan·Risk Class 1·MD·SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT·Registered Feb 26, 2016 – Feb 26, 2026Expired

Registration details

Analysis ID: 4e444071ca471323aeb4d5cd1da869a1
License Form: Ministry of Health Medical Device Import No. 016198
Customs Code: DHA09401619804

Company information

Manufacturer: SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT
Manufacturer Country: Japan
Authorized Representative: KUO'S YUAN IN ENTERPRISE CO., LTD.

Product details

Intended Use: Limited to the first level recognition range of lactate dehydrogenase test system (A.1440) of the management method for medical devices.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A1440 Lactate dehydrogenase test system
Import Information: Imported from abroad

Dates and status

Registration Date: Feb 26, 2016
Expiry Date: Feb 26, 2026

About this record

Access comprehensive regulatory information for "SEKISUI" Pureauto S LD-P (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 4e444071ca471323aeb4d5cd1da869a1 and manufactured by SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT. The authorized representative in Taiwan is KUO'S YUAN IN ENTERPRISE CO., LTD..

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