Taiwan FDA registration a0d9ebbf18641e51802657f1d84b64e4

Ion Cell Separator II

TW: 亞恩血球細胞分離器 II

Taiwan·Risk Class 2·AEON BIOTHERAPEUTICS CORP.·Registered Nov 10, 2023 – Nov 10, 2028Active

Registration details

Analysis ID: a0d9ebbf18641e51802657f1d84b64e4

Company information

Manufacturer: AEON BIOTHERAPEUTICS CORP.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: AEON BIOTHERAPEUTICS CORP.

Product details

Intended Use: This product can be used for blood collection and processing, blood is drawn from the patient, and autologous platelet rich plasma (PRP) is separated to prepare autologous platelet thick fluid (PRP).
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.9245 Automated hemocytoseparator
Import Information: 國產;; QMS/QSD

Dates and status

Registration Date: Nov 10, 2023
Expiry Date: Nov 10, 2028

About this record

Access comprehensive regulatory information for Ion Cell Separator II in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number a0d9ebbf18641e51802657f1d84b64e4 and manufactured by AEON BIOTHERAPEUTICS CORP.. The authorized representative in Taiwan is AEON BIOTHERAPEUTICS CORP..

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