Taiwan FDA registration 2fa0fe3a8e352fcac035ef3eff66657e

"Dias" orbital automatic red blood cell sedimentation rate meter (unsterilized)

TW: “迪雅仕”軌道式自動紅血球沉降速率儀 (未滅菌)

Taiwan·Risk Class 1·DIESSE DIAGNOSTICA SENESE S.P.A.·Registered Oct 26, 2018 – Oct 26, 2028Active

Registration details

Analysis ID: 2fa0fe3a8e352fcac035ef3eff66657e
Customs Code: DHA09401973302

Company information

Manufacturer: DIESSE DIAGNOSTICA SENESE S.P.A.
Manufacturer Country: Italy
Authorized Representative: GRAND MARQUIS CO., LTD.

Product details

Intended Use: It is limited to the first level of identification scope of the "Automatic Sedimentation Rate Device (B.5800)" of the Administrative Measures for the Classification and Grading of Medical Devices.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.5800 Automatic settling rate device
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Oct 26, 2018
Expiry Date: Oct 26, 2028

About this record

Access comprehensive regulatory information for "Dias" orbital automatic red blood cell sedimentation rate meter (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 2fa0fe3a8e352fcac035ef3eff66657e and manufactured by DIESSE DIAGNOSTICA SENESE S.P.A.. The authorized representative in Taiwan is GRAND MARQUIS CO., LTD..

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