Taiwan FDA registration 191ae0dec2d0c6d4f141b0221b289fe6

"Sigmatic" limb equipment (unsterilized)

TW: “適美得”肢體裝具(未滅菌)
Taiwan flagTaiwan·Risk Class 1·Yuan Billion Enterprise Limited;; Dongda Medical Equipment Co., Ltd·Registered Oct 01, 2021 – Oct 31, 2024Expired
Registration details
Analysis ID
191ae0dec2d0c6d4f141b0221b289fe6
Company information
Manufacturer Country
Taiwan, Province of China
Authorized Representative
Dongda Medical Equipment Co., Ltd
Product details
Intended Use
Limited to the first level recognition range of limb equipment (O.3475) of the Measures for the Administration of Medical Devices.
Product Type (Level 1)
o Physical Medical Sciences
Product Type (Level 2)
O.3475 Limb fittings
Import Information
Domestic;; Contract manufacturing
Dates and status
Registration Date
Oct 01, 2021
Expiry Date
Oct 31, 2024
Cancellation Date
Aug 11, 2023
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About this record

Access comprehensive regulatory information for "Sigmatic" limb equipment (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 191ae0dec2d0c6d4f141b0221b289fe6 and manufactured by Yuan Billion Enterprise Limited;; Dongda Medical Equipment Co., Ltd. The authorized representative in Taiwan is Dongda Medical Equipment Co., Ltd.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including YUAN BOR YIH ENTERPRISE CO., LTD., and 1 recent registrations in the same category. 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.

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