Taiwan FDA registration e8a13f5d71e265ae3003b56a005ff592

Cygnus Auto CRE

TW: 筱原希格納斯肌酸酐試驗系統

Taiwan·Risk Class 2·MD·SHINO-TEST CORPORATION, SAGAMIHARA PRODUCTION CENTER·Registered Aug 27, 2018 – Aug 27, 2028Active

Registration details

Analysis ID: e8a13f5d71e265ae3003b56a005ff592
License Form: Ministry of Health Medical Device Import No. 031436
Customs Code: DHA05603143600

Company information

Manufacturer: SHINO-TEST CORPORATION, SAGAMIHARA PRODUCTION CENTER
Manufacturer Country: Japan
Authorized Representative: MEDICARE PRODUCTS INC.

Product details

Intended Use: This product uses enzyme analysis to measure creatinine concentration in serum, plasma or urine.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A1225 Creatinine Test System
Import Information: Imported from abroad

Dates and status

Registration Date: Aug 27, 2018
Expiry Date: Aug 27, 2028

About this record

Access comprehensive regulatory information for Cygnus Auto CRE in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e8a13f5d71e265ae3003b56a005ff592 and manufactured by SHINO-TEST CORPORATION, SAGAMIHARA PRODUCTION CENTER. The authorized representative in Taiwan is MEDICARE PRODUCTS INC..

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