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"Cloud Elephant" bone marrow smear digital pattern analysis software - Taiwan Registration ebee89d1db1a1997b51927902b9e2b5f

Access comprehensive regulatory information for "Cloud Elephant" bone marrow smear digital pattern analysis software in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ebee89d1db1a1997b51927902b9e2b5f and manufactured by aetherAI Co., Ltd.. The authorized representative in Taiwan is aetherAI Co., Ltd..

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ebee89d1db1a1997b51927902b9e2b5f
Registration Details
Taiwan FDA Registration: ebee89d1db1a1997b51927902b9e2b5f
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Device Details

"Cloud Elephant" bone marrow smear digital pattern analysis software
TW: โ€œ้›ฒ่ฑกโ€้ชจ้ซ“ๆŠน็‰‡ๆ•ธไฝๅž‹ๆ…‹ๅˆ†ๆž่ปŸ้ซ”
Risk Class 2

Registration Details

ebee89d1db1a1997b51927902b9e2b5f

Company Information

Taiwan, Province of China

Product Details

This product is a pure software medical material, which can locate the blood cell image in the specific field of view of the bone marrow smear selected by the user, and provide an estimate of the blood cell classification count, and the operator needs to identify and confirm the speculative category of each cell according to the pattern. This product is intended to assist haematologists and medical examiners in the Division of Laboratory Medicine in identifying, classifying and counting the types and quantities of bone marrow cells during bone marrow smear reading. This product has poor interpretation results for Metamyelocyte, Proerythroblast, Basophils and precursors, Monocytes and precursors and Histiocytes and precursors, and it is recommended that users read it carefully.

B Hematology, pathology, and genetics

B.9999 Miscellaneous

QMS/QSD;; ๅœ‹็”ข

Dates and Status

Oct 04, 2021

Oct 04, 2026