Taiwan FDA registration b824213af9d339327d67c66728fa6c07

"Baxter" Aite bone replacement (plasticable)

TW: “百特”艾特骨替代物(可塑形)

Taiwan·Risk Class 2·Baxter Healthcare Corporation;; Apatech Ltd.·Registered Apr 07, 2022 – Apr 07, 2027Active

Registration details

Analysis ID: b824213af9d339327d67c66728fa6c07
Customs Code: DHA05603537309

Company information

Manufacturer: Baxter Healthcare Corporation;; Apatech Ltd.
Manufacturer Country: United Kingdom;;United States
Authorized Representative: BAXTER HEALTHCARE LTD.

Product details

Intended Use: Details are as detailed as approved Chinese instructions
Product Type (Level 1): N Orthopedics
Product Type (Level 2): N.3045 Absorbable Calcium Salt Bone Cavity Filling Device
Import Information: import

Dates and status

Registration Date: Apr 07, 2022
Expiry Date: Apr 07, 2027

About this record

Access comprehensive regulatory information for "Baxter" Aite bone replacement (plasticable) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b824213af9d339327d67c66728fa6c07 and manufactured by Baxter Healthcare Corporation;; Apatech Ltd.. The authorized representative in Taiwan is BAXTER HEALTHCARE LTD..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.