Taiwan FDA registration 0ccf110a74f68a760f64d6e0bd09139c

"Aritek" erythrocyte sedimentation rate meter (unsterilized)

TW: “艾利鐵克”紅血球沉降速率儀(未滅菌)

Taiwan·Risk Class 1·ELITechGroup B.V.·Registered Nov 20, 2018 – Nov 20, 2023Expired

Registration details

Analysis ID: 0ccf110a74f68a760f64d6e0bd09139c
Customs Code: DHA09401983102

Company information

Manufacturer: ELITechGroup B.V.
Manufacturer Country: Netherlands
Authorized Representative: ARSENALS IVD 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: Nov 20, 2018
Expiry Date: Nov 20, 2023

About this record

Access comprehensive regulatory information for "Aritek" erythrocyte 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 0ccf110a74f68a760f64d6e0bd09139c and manufactured by ELITechGroup B.V.. The authorized representative in Taiwan is ARSENALS IVD CO., LTD..

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