Taiwan FDA registration ebee89d1db1a1997b51927902b9e2b5f

"Cloud Elephant" bone marrow smear digital pattern analysis software

TW: “雲象”骨髓抹片數位型態分析軟體

Taiwan·Risk Class 2·aetherAI Co., Ltd.·Registered Oct 04, 2021 – Oct 04, 2026Active

Registration details

Analysis ID: ebee89d1db1a1997b51927902b9e2b5f

Company information

Manufacturer: aetherAI Co., Ltd.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: aetherAI Co., Ltd.

Product details

Intended Use: 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.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.9999 Miscellaneous
Import Information: QMS/QSD;; 國產

Dates and status

Registration Date: Oct 04, 2021
Expiry Date: Oct 04, 2026

About this record

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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